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STUDY OBJECTIVES: This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning. METHODS: A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures. RESULTS: A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all P < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring. CONCLUSIONS: Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303. CITATION: Tu AY, Crawford MR, Dawson SC, et al. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022;18(3):789–800.

Objective To examine the individual and combined effects of daytime sleepiness and insomnia disorder (ID) on measures of cognitive functioning. Design and setting This study was conducted at a medical center using a cross-sectional research design. Participants 35 persons with ID (Mage = 40.6 years; 25 women) and 54 normal sleepers (NS; Mage = 31.5 years; 38 women). Methods and measures Participants underwent two nights of home-based polysomnography (PSG) followed by daytime testing with a four-trial Multiple Sleep Latency Test (MSLT). Before each MSLT nap, they completed a computer-administered battery of reaction time tasks. Measures of response latencies and response accuracy were tabulated and used as dependent measures. The ID and NS groups were each subdivided into “alert” (eg, MSLT mean latency > 8 min) and “sleepy” (eg, MSLT mean latency ≤ 8 min) subgroups to identify hyperaroused persons with ID and allow for their comparisons with the other participant subgroups. Results Multivariate analyses of variance showed a significant main effect for level of daytime sleepiness (F [1, 84] = 8.52, p = 0.0045) on simpler performance tasks and a significant main effect for presence vs. absence of ID (F [1,84] = 6.62, p = 0.012) on complex tasks. A lack of significant participant type x MSLT alertness level interactions in study analyses suggested those ID participants with presumed hyperaousal were not relatively more impaired than the other participant subgroups. Conclusions Daytime performance deficits on simple tasks seem most dependent on individuals’ levels of daytime sleepiness, whereas performance deficits on more complex tasks appears related to the presence of ID. Therefore, it seems best to use complex performance measures both to document cognitive deficits among those with ID and to determine if insomnia treatments reduce such impairments. Trial registration ClinicalTrials.gov Identifier: NCT02290405.

INTRODUCTION: This guideline establishes clinical practice recommendations for the use of behavioral and psychological treatments for chronic insomnia disorder in adults. METHODS: The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine and sleep psychology to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The task force evaluated a summary of the relevant literature and the quality of evidence, the balance of clinically relevant benefits and harms, patient values and preferences, and resource use considerations that underpin the recommendations. The AASM Board of Directors approved the final recommendations. RECOMMENDATIONS: The following recommendations are intended as a guide for clinicians in choosing a specific behavioral and psychological therapy for the treatment of chronic insomnia disorder in adult patients. Each recommendation statement is assigned a strength (“strong” or “conditional”). A “strong” recommendation (ie, “We recommend…”) is one that clinicians should follow under most circumstances. A “conditional” recommendation is one that requires that the clinician use clinical knowledge and experience, and to strongly consider the patient’s values and preferences to determine the best course of action. 1. We recommend that clinicians use multicomponent cognitive behavioral therapy for insomnia for the treatment of chronic insomnia disorder in adults. (STRONG). 2. We suggest that clinicians use multicomponent brief therapies for insomnia for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 3. We suggest that clinicians use stimulus control as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 4. We suggest that clinicians use sleep restriction therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 5. We suggest that clinicians use relaxation therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 6. We suggest that clinicians not use sleep hygiene as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). CITATION: Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(2):255–262.

INTRODUCTION: The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of behavioral and psychological treatments for chronic insomnia disorder in adult populations. METHODS: The American Academy of Sleep Medicine commissioned a task force of 9 experts in sleep medicine and sleep psychology. A systematic review was conducted to identify randomized controlled trials that addressed behavioral and psychological interventions for the treatment of chronic insomnia disorder in adults. Statistical analyses were performed to determine if the treatments produced clinically significant improvements in a range of critical and important outcomes. Finally, the Grading of Recommendations Assessment, Development, and Evaluation process was used to evaluate the evidence for making specific treatment recommendations. RESULTS: The literature search identified 1,244 studies; 124 studies met the inclusion criteria, and 89 studies provided data suitable for statistical analyses. Evidence for the following interventions is presented in this review: cognitive-behavioral therapy for insomnia, brief therapies for insomnia, stimulus control, sleep restriction therapy, relaxation training, sleep hygiene, biofeedback, paradoxical intention, intensive sleep retraining, and mindfulness. This review provides a detailed summary of the evidence along with the quality of evidence, the balance of benefits vs harms, patient values and preferences, and resource use considerations. CITATION: Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021;17(2):263–298.

Study Objectives It is common to provide insomnia patients a second treatment when the initial treatment fails, but little is known about optimal treatment sequences for different patient types. This study examined whether pre-treatment characteristics/traits predict optimal treatment sequences for insomnia patients. Methods A community sample of 211 adults (132 women; Mage = 45.6 ± 14.9 years) with insomnia were recruited. Patients were first treated with behavioral therapy (BT) or zolpidem (Zol). Non-remitting BT recipients were randomized to a second treatment with either Zol or cognitive therapy; non-remitting Zol recipients underwent BT or Trazodone as a second treatment. Remission rates were assessed at the end of the first and second 6-week treatments. We then compared the remission rates of dichotomous groups formed on the basis of gender, age, pretreatment scores on SF36 and Multidimensional Fatigue Scale, the presence/absence of psychiatric/medical comorbidities or pain disorders, and mean subjective sleep duration and efficiency within and across treatment sequences. Results Lower remission rates were noted for those: with a pain disorder, poor mental health perceptions, high MFI fatigue scores, and lower sleep times and efficiencies. Patients with a pain disorder responded best to the BT-to-Zol sequence, whereas patients with more mental impairment, severe fatigue, short sleep, and low sleep efficiency responded poorly to treatment starting with BT. Conclusions Pain, fatigue, poor mental health status, and subjective sleep duration and efficiency all affect response to different insomnia treatment sequences. Findings may guide clinicians in matching insomnia treatments to their patients. Clinical Trial Registration ClinicalTrials.gov Identifier: NCT01651442, Protocol version 4, April 20, 2011, registered June 26, 2012, https://clinicaltrials.gov/ct2/show/NCT01651442?rslt=With&type=Intr&cond=Insomnia&cntry=US&state=US%3ACO&city=Denver&age=12&draw=2&rank=1.

Study Objectives To investigate treatment models using cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) for people with obstructive sleep apnea (OSA) and comorbid insomnia. Methods 121 adults with OSA and comorbid insomnia were randomized to receive CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only. PAP was delivered following standard clinical procedures for in-lab titration and home setup and CBT-I was delivered in four individual sessions. The primary outcome measure was PAP adherence across the first 90 days, with regular PAP use (≥4 h on ≥70% of nights during a 30-day period) serving as the clinical endpoint. The secondary outcome measures were the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI 7) serving as the clinical endpoints. Results No significant differences were found between the concomitant treatment arms and PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint. Compared to PAP alone, the concomitant treatment arms reported a significantly greater reduction from baseline on the ISI (p = .0009) and had a greater percentage of participants who were good sleepers (p = .044) and remitters (p = .008). No significant differences were found between the sequential and concurrent treatment models on any outcome measure. Conclusions The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP.

Insomnia disorder is common in adults and children. The estimated prevalence ranges from 9% to 15% in the general population, with higher prevalence in certain subpopulations. Hypnotic medications are those that tend to produce sleep and are frequently used to treat insomnia. Commonly used hypnotics in adults include benzodiazepines (BZDs), BZD receptor agonists, antihistamines, antidepressants, melatonin receptor agonists, orexin receptor antagonists, and antipsychotics. However, hypnotic discontinuation is difficult and often unsuccessful. This article discusses strategies to discontinue hypnotics and evidence supporting their use.

Introduction Cognitive behavioral therapy for insomnia (CBT-I) reduces insomnia severity among individuals with insomnia and major depressive disorder (MDD). Understanding the long-term trajectories of insomnia symptom severity has the potential to inform optimization of CBT-I in this population. The objectives of this study were to examine trajectories of change in insomnia severity over a 16-week treatment phase and 2-year naturalistic follow-up, and explore correlates of symptom trajectories. Methods 148 adults (age 46.6±12.6, 73.0% female) with insomnia and MDD were randomly assigned to receive depression pharmacotherapy plus seven sessions of either CBT-I or control insomnia therapy. Depression and insomnia severity were assessed via the Hamilton Depression Rating Scale and Insomnia Severity Index at baseline, bi-weekly during treatment, and every 4 months over follow-up. Sleep effort and beliefs about sleep were assessed at baseline, midtreatment, and posttreatment. Results Latent class linear mixed modeling revealed four insomnia response trajectories: 1) Early Sustained-Responders (16%) showed marked improvement early in treatment, sustained over follow-up; 2) Gradual-Responders (36.7%) achieved substantial symptom reduction by posttreatment, sustained over follow-up; 3) Initial-Responders (25.3%) had substantial symptom reduction during treatment but increased in severity over follow-up; and 4) Partial-Responders (20.7%) achieved minimal improvement over treatment, and maintained moderate symptom severity over follow-up. Chi-square analyses revealed that classes did not differ significantly on sex, ethnicity, employment, relationship status, or treatment received (all ps > .05). One-way ANOVAs with Tukey’s HSD, showed that Partial-Responders consistently endorsed higher depressive symptom severity, sleep effort, and unhelpful beliefs about sleep at baseline, throughout treatment, and follow-up (ps < .05). Early Sustained-Responders endorsed lower sleep effort by midtreatment (ps < .01). Conclusion Results suggest four temporal patterns of treatment response and identified clinical correlates. Future work will be needed to determine if addressing sleep effort early in the course of treatment might enhance sustained insomnia outcome. Support MH078924, MH078961, MH079256

Objective To determine the best of commonly used methods for computing the rate of decline in non-rapid eye movement (NREM) sleep EEG delta power overnight (Delta Decline) in terms of vulnerability to missing data and to evaluate whether this rate is slower in insomnia patients than healthy controls (HC). Methods Fifty-one insomnia patients and 53 HC underwent 6 nights of polysomnography. Four methods for estimating Delta Decline were compared (exponential and linear best-fit functions using NREM (1) episode mean, (2) peak, and (3) total delta power and (4) delta power for all available NREM epochs). The best method was applied to compare groups on linear and exponential rates of Delta Decline. Results Best-fit models using all available NREM epochs were significantly less vulnerable to deviation due to missing data than other methods. Insomnia patients displayed significantly slower linear and exponential Delta Decline than HC. Conclusions Computing Delta Decline using all available NREM epochs was the best of the methods studied for minimizing the effects of missing data. Insomnia patients display slower Delta Decline, which is not explained by differences in total sleep time or wake after sleep onset. Significance This study supports using all available NREM epochs in Delta Decline computation and suggests a slower rate in insomnia.

Sleep is essential for survival and plays a key role in maintaining our physical and mental health. Over the past 40 years, the field of sleep medicine has increasingly focused on the role sleep disturbances have in the etiology of medical and psychological disorders and has proposed various methods of classifying sleep disorders as distinct clinical entities or as conditions occurring comorbid to various disorders. This chapter will provide a brief overview of sleep and sleep staging, the current classification systems used for sleep/wake disorders, a description of common sleep disorders and their relationship to various medical and mental health disorders, and frequently used assessment tools used to aid in diagnosis of sleep/wake disorders. The concluding section considers limitations to the classification systems and provides suggestions for future research.

Introduction Many patients have difficulties achieving hypnotic discontinuation due to anxiety that arises when they knowingly reduce their hypnotic dose or withhold it entirely. This study tested a blinded tapering approach to reduce patients’ anxiety and help them discontinue their hypnotics. Methods The study sample included 78 (M age = 55.2 ± 12.8 yrs.; 65.4% women) users of benzodiazepine and benzodiazepine receptor agonists. Following baseline assessments, enrollees first completed 4 sessions of cognitive behavioral insomnia therapy (CBTI). Subsequently they were randomized to one of three 20-week, double-blinded tapering protocols wherein their medication dosage either remained unchanged (CTRL) or was reduced by 25% or 10% every two weeks. At the end of the 20-week period the study blind was eliminated and those who completed one of the two blinded tapering protocols entered a 3-month follow-up period, whereas CTRL participants were offered an open label taper before completing the follow-up. Results Among those who completed one of the blinded tapering protocols, 92.9% totally discontinued their medication use by the end of the 20-week tapering phase, whereas 77.3% in the CTRL group discontinued hypnotic use by the end of their open label tapering. At follow-up 72.1% of those who completed blinded tapering remained medication free whereas only 52% of those who underwent open-label tapering remained medication free. Comparisons at follow-up showed those who received the open-label taper continued to use hypnotics on average 2.06 nights/week compared to .051 times per week for the blinded taper group (p = .042). The average weekly diazepam equivalent dose of medication used by the open label tapering group was 11.29 mg whereas the weekly dose for the blinded tapering group was 3.22 (p = .069). Conclusion CBTI combined with blinded hypnotic tapering is a promising treatment approach for helping hypnotic users overcome their medication dependence. Support (if any) National Institute of Drug Abuse, Grant # R34 DA042329-01

OBJECTIVES To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management. METHODS This study used a randomized, parallel group, clinical intervention trial design. A total of 137 adult (29 women) VA outpatients with sleep complaints were enrolled and randomly assigned to (1) an intervention (INT) consisting of a one-time consultation with a sleep specialist who provided diagnostic feedback and treatment recommendations to the patient and the patient's primary care provider; or (2) a control condition consisting of their usual primary care (UPC). Provider-focused outcomes included rates of adherence to recommended diagnostic procedures and sleep-focused interventions. Patient-focused outcomes included measures taken from sleep diaries and actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report measures of sleepiness, fatigue, mood, quality of life, and satisfaction with health care. RESULTS The proportions of provider-initiated sleep-focused interventions were significantly higher in the INT group than in the UPC group for polysomnography referrals (49% versus 6%; P < 0.001) and mental health clinic referrals (19% versus 6%; P = 0.02). At the 10-mo follow up, INT recipients showed greater estimated mean reductions in diary total wake time (-17.0 min; 95% confidence interval [CI]: -30.9, -3.1; P = 0.02) and greater increases in sleep efficiency (+3.7%; 95% CI: 0.8, 6.5; P = 0.01) than did UPC participants. A greater proportion of the INT group showed ≥ 1 standard deviation decline on the PSQI from baseline to the 10-mo follow-up (41% versus 21%; P = 0.02). Moreover, 69% of the INT group had normal (≤ 10) Epworth Sleepiness Scale scores at the 10-mo follow-up, whereas only 50% of the UPC group fell below this clinical cutoff (P = 0.03). CONCLUSIONS A one-time sleep consultation significantly increased healthcare providers' attention to sleep problems and resulted in benefits to patients' sleep/wake symptoms. CLINICAL TRIALS REGISTRATION This study is registered with clinicaltrials.gov with identifier # NCT00390572.

Importance Despite evidence of efficacious psychological and pharmacologic therapies for insomnia, there is little information about what first-line treatment should be and how best to proceed when initial treatment fails. Objective To evaluate the comparative efficacy of 4 treatment sequences involving psychological and medication therapies for insomnia and examine the moderating effect of psychiatric disorders on insomnia outcomes. Design, Setting, and Participants In a sequential multiple-assignment randomized trial, patients were assigned to first-stage therapy involving either behavioral therapy (BT; n = 104) or zolpidem (zolpidem; n = 107), and patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT]). The study took place at Institut Universitaire en Sante Mentale de Quebec, Universite Laval, Quebec City, Quebec, Canada, and at National Jewish Health, Denver, Colorado, and enrollment of patients took place from August 2012 through July 2017. Main Outcomes and Measures The primary end points were the treatment response and remission rates, defined by the Insomnia Severity Index total score. Results Patients included 211 adults (132 women; mean [SD] age, 45.6 [14.9] years) with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder. First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%; OR, 1.41; 95% CI, 0.75-2.65). Second-stage therapy produced significant increases in responders for the 2 conditions, starting with BT (BT to zolpidem, 40.6% to 62.7%; OR, 2.46; 95% CI, 1.14-5.30; BT to CT, 50.1% to 68.2%; OR, 2.09; 95% CI, 1.01-4.35) but no significant change following zolpidem treatment. Significant increase in percentage of remitters was observed in 2 of 4 therapy sequences (BT to zolpidem, 38.1% to 55.9%; OR, 2.06; 95% CI, 1.04-4.11; zolpidem to trazodone, 31.4% to 49.4%; OR, 2.13; 95% CI, 0.91-5.00). Although response/remission rates were lower among patients with psychiatric comorbidity, treatment sequences that involved BT followed by CT or zolpidem followed by trazodone yielded better outcomes for patients with comorbid insomnia. Response and remission rates were well sustained through the 12-month follow-up. Conclusions and Relevance Behavioral therapy and zolpidem medication produced equivalent response and remission rates. Adding a second treatment produced an added value for those whose insomnia failed to remit with initial therapies. Trial Registration ClinicalTrials.gov Identifier:NCT01651442

Introduction Many patients have difficulties achieving hypnotic discontinuation due to anxiety that arises when they knowingly reduce their hypnotic dose or withhold it entirely. This study tested a blinded tapering approach to reduce patients’ anxiety and help them discontinue their hypnotics. Methods The study sample included 78 (M age = 55.2 ± 12.8 yrs.; 65.4% women) users of benzodiazepine and benzodiazepine receptor agonists. Following baseline assessments, enrollees first completed 4 sessions of cognitive behavioral insomnia therapy (CBTI). Subsequently they were randomized to one of three 20-week, double-blinded tapering protocols wherein their medication dosage either remained unchanged (CTRL) or was reduced by 25% or 10% every two weeks. At the end of the 20-week period the study blind was eliminated and those who completed one of the two blinded tapering protocols entered a 3-month follow-up period, whereas CTRL participants were offered an open label taper before completing the follow-up. Results Among those who completed one of the blinded tapering protocols, 92.9% totally discontinued their medication use by the end of the 20-week tapering phase, whereas 77.3% in the CTRL group discontinued hypnotic use by the end of their open label tapering. At follow-up 72.1% of those who completed blinded tapering remained medication free whereas only 52% of those who underwent open-label tapering remained medication free. Comparisons at follow-up showed those who received the open-label taper continued to use hypnotics on average 2-3 nights/week compared to about 1 time every other week for the blinded taper group (p = .05). The average weekly diazepam equivalent dose of medication used by the open label tapering group was about 5 times higher than the average weekly dose used by the blind tapering group (p = .025). Conclusion CBTI combined with blinded hypnotic tapering is a promising treatment approach for helping hypnotic users overcome their medication dependence. Support National Institute of Drug Abuse, Grant # R34 DA042329-01

Introduction Early termination (i.e., dropout) from cognitive-behavioral therapy for insomnia (CBT-I) likely attenuates benefits and may reduce motivation for future treatment. The aim of the current study was to identify characteristics of participants who dropped out of CBT-I in an RCT of combined treatment for depression and insomnia. Methods Participants were 148 adults with comorbid insomnia and depression diagnoses (73% female; M age = 46.6[SD = 12.6]) who were randomly assigned to receive depression pharmacotherapy plus 7 weekly sessions of CBT-I (n = 73) or a credible control therapy for insomnia (n = 75). Receiver operating characteristic curve (ROC) analyses were performed to determine which participant characteristics (i.e., demographics, baseline depression and sleep variables) predicted dropout at session 4 (i.e., minimum dose) and session 7 (i.e., full course of CBT-I). Results Early termination (prior to session 4) rate was 28% and ROC analyses indicated participants aged 36 or less were more likely to drop out than those older than 36 (49% vs. 22%). The model did not identify additional predictors for either of the two age categories. Overall termination (prior to session 7) rate was 45% and ROC analyses indicated participants aged 46 or less were more likely to drop out than those older than 46 (61% vs. 34%). The model further found that among participants aged 46 or less, those with less than 14y education were at greater risk for dropout than those with greater than 14y education (79% vs. 46%). No other demographic, depression, or sleep variables were significant predictors of dropout. Conclusion Age was associated with elevated rate of dropout from CBT-I among individuals with co-occurring depression and insomnia. It appears that the combination of younger age and lower education level is particularly detrimental to treatment engagement. Better understanding of factors that contribute to dropout from CBT-I in this vulnerable group can guide development of retention strategies. Support MH078924, MH078961, MH079256

Introduction This study examines the effects of treatment sequences using cognitive-behavioral therapy for insomnia (CBT-I) and continuous positive airway pressure (CPAP) therapy on daytime functioning in people with comorbid insomnia and sleep apnea (COMISA). Methods 118 participants with COMISA (Age=49.99±13.12; 53.4% female) were randomized to one of the three study arms: Arm A- CBT-I followed by CPAP, Arm B- CBT-I concurrent with CPAP, and Arm C- CPAP only. Participants were assessed at four time points [baseline/ start of phase 1 (A1), CPAP titration/ start of phase 2 (A2), 30 days (A3) and 90 days (A4) after CPAP initiation]. This study examined secondary outcome measures of daytime functioning, including the Functional Outcomes of Sleep Questionnaire (FOSQ), Epworth Sleepiness Scale, and Flinders Fatigue Scale (FFS). Results Linear mixed model analyses showed a main effect of time on improving functional outcomes in all measurements, with all p< 0.001. There were also arm by time interactions on FOSQ [F(6, 105.36)=4.21, p=0.001] and FFS scores [F(6, 106.95)=3.10, p=0.008]. Pairwise comparisons with Bonferroni adjustment showed improved FOSQ scores in Arm A from A1 to A2 (p=0.011) and A2 to A3 (p=0.005), Arm B from A2 to A3 (p< 0.001), and Arm C from A2 to A3 (p=0.006). For FFS scores, improvements were shown in Arm A from A1 to A2 (p=0.003), and Arm B from A2 to A3 (p < 0.001). Conclusion The results show daytime functioning improvements in patients with COMISA following CPAP and CBT-I. In addition, CBT-I appears to facilitate improvement in sleepiness-related functional status and daytime fatigue. The findings suggest that the combination of CBT-I and CPAP may have a beneficial effect on daytime functioning in patients with COMISA. Support This study was supported by the National Institutes of Health (R01HL114529).

The American Academy of Sleep Medicine (AASM) commissioned five Workgroups to develop quality measures to optimize management and care for patients with common sleep disorders including insomnia. Following the AASM process for quality measure development, this document describes measurement methods for two desirable outcomes of therapy, improving sleep quality or satisfaction, and improving daytime function, and for four processes important to achieving these goals. To achieve the outcome of improving sleep quality or satisfaction, pre- and post-treatment assessment of sleep quality or satisfaction and providing an evidence-based treatment are recommended. To realize the outcome of improving daytime functioning, pre- and post-treatment assessment of daytime functioning, provision of an evidence-based treatment, and assessment of treatment-related side effects are recommended. All insomnia measures described in this report were developed by the Insomnia Quality Measures Workgroup and approved by the AASM Quality Measures Task Force and the AASM Board of Directors. The AASM recommends the use of these measures as part of quality improvement programs that will enhance the ability to improve care for patients with insomnia.

In this meta-analysis, we compare the short-term efficacy of prazosin vs. IRT on nightmares, sleep quality, and posttraumatic stress symptoms (PTSS).Reference databases were searched for randomized controlled trials using IRT or prazosin for nightmares, sleep disturbance, and/or PTSS. Effect sizes were calculated by subtracting the mean posttest score in the control group from the mean posttest score in the treatment group, and dividing the result by the pooled standard deviation of both groups. Mixed effects models were performed to evaluate effects of treatment characteristics, as well as sample characteristics (veteran vs. civilian) on treatment efficacy.Four studies used prazosin, 10 used IRT alone or in combination with another psychological treatment, and 1 included a group receiving prazosin and another group receiving IRT. Overall effect sizes of both treatments were of moderate magnitude for nightmare frequency, sleep quality, and PTSS (p0.01). Effect size was not significantly different with type of treatment (psychological vs. pharmacological) on nightmare frequency (p = 0.79), sleep quality (p = 0.65), or PTSS, (p = 0.52). IRT combined with CBT for insomnia showed more improvement in sleep quality compared to prazosin (p = 0.03), IRT alone (p = 0.03), or IRT combined with another psychological intervention, (p0.01).Although IRT interventions and prazosin yield comparable acute effects for the treatment of nightmares, adding CBT for insomnia to IRT seems to enhance treatment outcomes pertaining to sleep quality and PTSS. More randomized clinical trials with long-term follow-up are warranted.A commentary on this article appears in this issue on page 9.

Study Objectives: This study examined empirically derived symptom cluster profiles among patients who present with insomnia using clinical data and polysomnography. Methods: Latent profile analysis was used to identify symptom cluster profiles of 175 individuals (63% female) with insomnia disorder based on total scores on validated self-report instruments of daytime and nighttime symptoms (Insomnia Severity Index, Glasgow Sleep Effort Scale, Fatigue Severity Scale, Beliefs and Attitudes about Sleep, Epworth Sleepiness Scale, Pre-Sleep Arousal Scale), mean values from a 7-day sleep diary (sleep onset latency, wake after sleep onset, and sleep efficiency), and total sleep time derived from an in-laboratory PSG. Results: The best-fitting model had three symptom cluster profiles: "High Subjective Wakefulness" (HSW), "Mild Insomnia" (MI) and "Insomnia-Related Distress" (IRD). The HSW symptom cluster profile (26.3% of the sample) reported high wake after sleep onset, high sleep onset latency, and low sleep efficiency. Despite relatively comparable PSG-derived total sleep time, they reported greater levels of daytime sleepiness. The MI symptom cluster profile (45.1%) reported the least disturbance in the sleep diary and questionnaires and had the highest sleep efficiency. The IRD symptom cluster profile (28.6%) reported the highest mean scores on the insomnia-related distress measures (eg, sleep effort and arousal) and waking correlates (fatigue). Covariates associated with symptom cluster membership were older age for the HSW profile, greater obstructive sleep apnea severity for the MI profile, and, when adjusting for obstructive sleep apnea severity, being overweight/obese for the IRD profile. Conclusions: The heterogeneous nature of insomnia disorder is captured by this data-driven approach to identify symptom cluster profiles. The adaptation of a symptom cluster-based approach could guide tailored patient-centered management of patients presenting with insomnia, and enhance patient care.

Study objective To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. Design A blinded, randomized split-plot experimental study. Setting Two urban academic clinical centers. Participants 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Interventions Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Measurements and results Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Conclusions Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH's sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of CBT-I.

Missing data, e.g. patient attrition, are endemic in sleep disorder clinical trials. Common approaches for dealing with this situation include complete-case analysis (CCA) and last observation carried forward (LOCF). Although these methods are simple to implement, they are deeply flawed in that they may introduce bias and underestimate uncertainty, leading to erroneous conclusions. There are alternative principled approaches, however, that are available in statistical software namely mixed-effects models and multiple imputation. In this paper we introduce terminology used to describe different assumptions about missing data. We emphasize that understanding reasons for missingness is a critical step in the analysis process. We describe and implement both linear mixed-effects models and an inclusive multiple imputation strategy for handling missing data in a randomized trial examining sleep outcomes. These principled strategies are compared with "complete-case analysis" and LOCF. These analyses illustrate that methodologies for accommodating missing data can produce different results in both direction and strength of treatment effects. Our goal is for this paper to serve as a guide to sleep disorder clinical trial researchers on how to utilize principled methods for incomplete data in their trial analyses.

Given the recent evidence on the association between hyperarousal in insomnia disorder and neurocognitive deficits, we aimed to examine the effect of short sleep duration on neurocognitive reaction time tests in insomnia disorder sufferers. We recruited subjects with insomnia disorder (n = 35, mean age = 40.6 years) who scored ≥29 on a Hyperarousal Scale, and a group of controls (n = 54, mean age = 31.5 years) who had no sleep disorders and scored

Study Objectives: To determine if vestibular stimulation is an effective therapy for transient insomnia in a sleep phase advance model.

Insomnia is a widespread and debilitating disorder. Regardless of the initial cause, it may assume a chronic course perpetuated by psychological and behavioral factors. Although sedative-hypnotic medications are the most common treatment for insomnia, they pose certain risks such as adverse effects and dependence. Furthermore, medications target symptoms and fail to address the underlying perpetuating mechanisms. There are many nonpharmacologic treatment options for insomnia, including cognitive/behavioral methods, relaxation strategies, and complementary and alternative medicine (CAM) approaches. Most CAM therapies lack sufficient scientific evidence to recommend their use. Over the past 30 years, cognitive-behavioral therapies have emerged as the treatment of choice for chronic insomnia. These therapies target behavioral, cognitive, and conditioning factors underlying insomnia, thereby restoring normal sleep-wake functioning. The effectiveness of these therapies is well established. They compare favorably to pharmacologic approaches, with the added benefits of few or no adverse effects and no risk of abuse or dependence. Perhaps most importantly, behavioral insomnia therapies offer a potential cure for the insomnia, instead of the symptom-focused approach provided by medications. Despite the proven success of cognitive-behavioral therapies, they are not widely available to patients with insomnia because of a paucity of behavioral sleep specialists. Efforts are now being made to disseminate these treatments to meet the demand. Emerging therapies hold promise for further refinement and development of successful treatments.

OBJECTIVES: To determine whether high-intensity ambient light in public areas of long-term care facilities will improve sleeping patterns and circadian rhythms of persons with dementia. DESIGN: A cluster-unit crossover intervention trial involving four conditions: morning bright light, evening bright light, all-day bright light, and minimum standard light. SETTING: The common areas of two geriatric units in a psychiatric hospital and a dementia-specific residential care facility. PARTICIPANTS: Sixty-six older adults with dementia. INTERVENTION: Ambient bright light of approximately 2,500 lux, delivered through a low-glare lighting system installed in the dining and activity areas. Participant exposure averaged 2.5 to 3.0 hours for the morning and evening interventions and 8.4 hours for the all-day intervention. MEASUREMENTS: Nighttime sleep using wrist actigraphy and daytime activity using nonobtrusive daytime observations. RESULTS: Night-time sleep increased significantly in participants exposed to morning and all-day light, with the increase most prominent in participants with severe or very severe dementia (mean increase 16 minutes (P=.008) for morning, and 14 minutes (P=.01) for all-day). Morning light produced a mean phase advance of 29 minutes (P=.02) and evening light a mean phase delay of 15 minutes (P=.06). Effects on daytime sleepiness were inconsistent, and the number of sleep bouts, mesor, amplitude, intradaily variability, and interdaily stability were not significantly different, indicating that the overall strength of day and night activity rhythms did not change significantly under any treatment condition. CONCLUSION: Bright light appears to have a modest but measurable effect on sleep in this population, and ambient light may be preferable to stationary devices such as light boxes.

Continuous positive airway pressure (CPAP) is a safe, effective treatment for obstructive sleep apnea, and yet many patients develop claustrophobic reactions to the CPAP nasal mask and cannot tolerate this treatment. We examined the efficacy of a graded in-vivo exposure therapy for enhancing CPAP adherence using a retrospective, case series design. Objective CPAP adherence data were obtained on clinical patients who attended 1 or more sessions of exposure therapy with a behavioral sleep psychologist. Compared to pre-treatment, patients used CPAP significantly longer after exposure therapy. No predictors of treatment response were identified. CPAP exposure therapy may be beneficial in some cases; however, further research is needed to determine types of patients most likely to benefit from this therapy.

Fibromyalgia (FM), characterized by diffuse myalgia, multiple topographically specific tender points, chronic fatigue, psychosocial distress, and disturbed, unrefreshing sleep, is a significant health problem. Clinical survey studies suggest that the majority of FM patients present with insomnia complaints, including difficulty initiating sleep, sleep maintenance problems, or persistent nonrestorative sleep. Studies of clinical FM patients have shown that a worsening of sleep enhances subsequent daytime distress and pain complaints, whereas exacerbations of daytime pain or psychosocial distress often are followed by increased nocturnal sleep disruption. Given such findings, it seems reasonable to speculate that sleep disturbance is mechanistically important to the etiology or symptom maintenance of the FM syndrome. This article provides an overview of FM-related sleep difficulties and their treatment.

Objectives The Treatment of Insomnia and Depression (TRIAD) study evaluated the efficacy of combining depression pharmacotherapy (using MED, an ecologically valid and generalizable antidepressant medication algorithm) with cognitive-behavioral therapy for insomnia (CBT-I) among individuals with comorbid insomnia and major depressive disorder (MDD) to determine if change in insomnia severity mediates antidepressant outcome. Methods This 16-week, 3-site, randomized controlled trial (RCT) randomly assigned 150 participants (recruited between March 2009 and August 2013), who met DSM-IV-TR criteria for insomnia and MDD and were not receiving treatment for either, to receive depression pharmacotherapy plus 7 sessions of either CBT-I or a credible control therapy for insomnia (CTRL). Depression pharmacotherapy followed a standardized 2-step algorithm, which included escitalopram, sertraline, and desvenlafaxine in a prescribed sequence. Primary measures were the Hamilton Depression Rating Scale and the depression module of the Structured Clinical Interview for DSM-IV Axis I Disorders, Research Version, Nonpatient Edition, administered by raters masked to treatment assignment, and the self-administered Insomnia Severity Index (ISI). Results CBT-I was superior to CTRL in reducing insomnia severity (P = .028). The overall difference in depression remission between the treatments was not statistically significant (44% in CBT-I and 36% in CTRL; number needed to treat = 15). However, planned secondary analysis revealed that improvements in insomnia at week 6 mediated eventual remission from depression, with early change in ISI predicting depression remission in the CBT-I (P = .0002) but not in the CTRL arm (P = .26). Conclusions CBT-I is an efficacious treatment for insomnia comorbid with MDD among patients treated with antidepressant medications. Improvement in insomnia may be related to the change in depression. Future studies should identify which patients are most likely to benefit from the addition of an insomnia-focused therapy to standard antidepressant treatments. Trial registration ClinicalTrials.gov identifier NCT00767624.

This chapter describes the history of psychological and behavioral therapies for insomnia, from their beginnings in the 1950s to their contemporary developments and applications. Until the mid-80s, various first-generation behavioral insomnia therapies were developed and tested in parallel. Although the nature and specific focus of these therapies varied significantly, the majority of them showed good treatment success. Yet their benefits were best described as moderate. Indeed, none of them represented an omnibus treatment that addressed the range of factors that purportedly sustain insomnia. Therefore, a more comprehensive multicomponent approach, called cognitive-behavioral therapy (CBT), began to gain popularity by the end of the 80s. Since then, there has been a large body of evidence showing that CBT is an effective treatment, mainly for primary insomnia. At the beginning of this millennium, a growing number of studies have demonstrated that CBT is also effective among insomnia patients who additionally suffer from significant sleep-confounding medical and psychiatric disorders. However, it has been argued that the field is not, as yet, at a point where patients can be offered a maximally effective treatment. In an attempt to enhance treatment outcomes, work in progress explores different combinations and treatment sequences of CBT and pharmacotherapy. Moreover, dissemination of this treatment remains as one of its major challenges. To improve its reach, novel strategies including training nontraditional CBT providers and using Web-based treatment delivery methods have received increasing research attention.

Background Recognition that psychological and behavioral factors play an important role in insomnia has led to increased interest in therapies targeting these factors. A review paper published in 1999 summarized the evidence regarding the efficacy of psychological and behavioral treatments for persistent insomnia. The present review provides an update of the evidence published since the original paper. As with the original paper, this review was conducted by a task force commissioned by the American Academy of Sleep Medicine in order to update its practice parameters on psychological and behavioral therapies for insomnia. Methods A systematic review was conducted on 37 treatment studies (N = 2246 subjects/patients) published between 1998 and 2004 inclusively and identified through Psyclnfo and Medline searches. Each study was systematically reviewed with a standard coding sheet and the following information was extracted: Study design, sample (number of participants, age, gender), diagnosis, type of treatments and controls, primary and secondary outcome measures, and main findings. Criteria for inclusion of a study were as follows: (a) the main sleep diagnosis was insomnia (primary or comorbid), (b) at least 1 treatment condition was psychological or behavioral in content, (c) the study design was a randomized controlled trial, a nonrandomized group design, a clinical case series or a single subject experimental design with a minimum of 10 subjects, and (d) the study included at least 1 of the following as dependent variables: sleep onset latency, number and/or duration of awakenings, total sleep time, sleep efficiency, or sleep quality. Results Psychological and behavioral therapies produced reliable changes in several sleep parameters of individuals with either primary insomnia or insomnia associated with medical and psychiatric disorders. Nine studies documented the benefits of insomnia treatment in older adults or for facilitating discontinuation of medication among chronic hypnotic users. Sleep improvements achieved with treatment were well sustained over time; however, with the exception of reduced psychological symptoms/ distress, there was limited evidence that improved sleep led to clinically meaningful changes in other indices of morbidity (e.g., daytime fatigue). Five treatments met criteria for empirically-supported psychological treatments for insomnia: Stimulus control therapy, relaxation, paradoxical intention, sleep restriction, and cognitive-behavior therapy. Discussion These updated findings provide additional evidence in support of the original review's conclusions as to the efficacy and generalizability of psychological and behavioral therapies for persistent insomnia. Nonetheless, further research is needed to develop therapies that would optimize outcomes and reduce morbidity, as would studies of treatment mechanisms, mediators, and moderators of outcomes. Effectiveness studies are also needed to validate those therapies when implemented in clinical settings (primary care), by non-sleep specialists. There is also a need to disseminate more effectively the available evidence in support of psychological and behavioral interventions to health-care practitioners working on the front line.

STUDY OBJECTIVE Recent efforts have been made to develop quantitative frequency, duration, and severity criteria for insomnia. The current study was conducted to test a range of frequency and severity criteria sets for discriminating primary insomnia sufferers from normal sleepers. PARTICIPANTS Seventy-two adults with primary insomnia and 88 age-matched normal sleepers. METHODS Participants completed 14 consecutive nights of sleep logs to monitor their home sleep patterns. Receiver-operator characteristic curve analyses were used to compare a range of severity and frequency criteria sets for discriminating the insomnia and normal-sleeper groups. In addition, sensitivity and specificity tests were conducted for a range of wake-time severity cutoffs based on 2-week mean sleep-log data. RESULTS Receiver-operator characteristic curve analyses showed that no 1 combination of severity and frequency criteria maximized sensitivity and specificity. Rather, the optimal frequency cutoff decreased as the severity criterion increased. Analyses of mean sleep-log data showed that an average sleep-onset latency or middle-of-the-night wake time (ie, time awake between sleep onset and final morning awakening) cutoff of 20 minutes or longer over 2 weeks of sleep-log monitoring appeared to best maximize sensitivity (94.4%) and specificity (79.6%) for insomnia classification. CONCLUSIONS The optimal quantitative insomnia criteria found herein differ from those previously proposed. Nonetheless, results suggest that quantitative criteria derived from sleep-log data may be useful for classification of primary insomnia.

Primary insomnia (PI) is a prevalent form of sleep difficulty that impairs diurnal functioning, reduces quality of life and enhances health care utilization/costs for millions worldwide. Whereas the underlying pathophysiology of PI remains poorly understood, it is widely accepted that a host of cognitive and behavioral factors play important roles in perpetuating this condition. As such, a multi-factorial, cognitive–behavioral therapy (CBT) has emerged as a “treatment of choice” for managing the sleep/wake complaints of PI sufferers. This article considers the nature and relative merits of CBT for treating PI patients. In addition, this article reviews studies supporting the general efficacy and clinical effectiveness of CBT for treating PI complaints. Issues related to treatment implementation as well as factors that mediate patients' responses to CBT and predict treatment acceptance/outcome are also considered. Finally, remaining questions regarding CBT's application to PI are considered, and suggestions for future research are provided.

Insomnia is a highly prevalent, often debilitating, and economically burdensome form of sleep disturbance caused by various situational, medical, emotional, environmental and behavioral factors. Although several consensually-derived nosologies have described numerous insomnia phenotypes, research concerning these phenotypes has been greatly hampered by a lack of widely accepted operational research diagnostic criteria (RDC) for their definition. The lack of RDC has, in turn, led to inconsistent research findings for most phenotypes largely due to the variable definitions used for their ascertainment. Given this problem, the American Academy of Sleep Medicine (AASM) commissioned a Work Group (WG) to review the literature and identify those insomnia phenotypes that appear most valid and tenable. In addition, this WG was asked to derive standardized RDC for these phenotypes and recommend assessment procedures for their ascertainment. This report outlines the WG's findings, the insomnia RDC derived, and research assessment procedures the WG recommends for identifying study participants who meet these RDC.

Polysomnography (PSG), the gold standard sleep-assessment methodology, is impractical for many applications. Although alternative assessment methodologies are available, it is not clear which most correlates with PSG measures. This study compared sleep log (SL), actigraphy (ACT), and the REMview (RV) device for estimating PSG sleep measures. Thirty-three participants with various sleep-disorder diagnoses underwent 1 night of monitoring with PSG, RV, ACT, and SL. RV provided accurate estimates of most sleep variables. The accuracy of ACT and SL estimates depended on the sleep variable. These findings indicate that the selection of an alternative methodology should consider the sleep measure of interest in addition to the relative merits and drawbacks of each device.

This study examined whether patients who have periodic limb movement disorder (PLMD), with or without comorbid restless legs syndrome (RLS), display the sleep-disruptive cognitive and behavioral anomalies found among primary insomnia sufferers. Archival data from a Sleep History Questionnaire, home-based polysomnography, and a sleep log were obtained for matched RLS/PLMD, primary insomnia, and noncomplaining volunteer samples. Statistical comparisons showed that the RLS/PLMD and primary insomnia samples differed significantly from the normal sleepers in regard to their propensities for certain sleep disruptive habits, perceived difficulties controlling pre-sleep cognitive activity, and their subjective sleep appraisals. These findings suggest RLS/PLMD patients display many of the cognitive and behavioral anomalies thought to perpetuate primary insomnia. Hence, behavioral interventions may be warranted for RLS/PLMD patients.