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BackgroundWeight reduction is a standard recommendation for obstructive sleep apnea (OSA) treatment in people with obesity or overweight; however, weight loss can be challenging to achieve and maintain without bariatric surgery. Currently, no approved anti-obesity medication has demonstrated effectiveness in OSA management. This study is evaluating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA in people with obesity.MethodsSURMOUNT-OSA, a randomized, placebo -controlled, 52-week phase 3 trial, is investigating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA (apnea hypopnea- index ≥15 events/h) in participants with obesity (body mass index ≥30 kg/m2) and an established OSA diagnosis. SURMOUNT-OSA is made of 2 intervention-specific appendices (ISAs): ISA-1 includes participants with no current OSA treatment, and ISA-2 includes participants using positive airway pressure therapy. Overall, 469 participants have been randomized 1:1 to receive tirzepatide or placebo across the master protocol (ISA-1, n = 234; ISA-2, n = 235). All participants are also receiving lifestyle intervention for weight reduction.ResultsThe primary endpoint for the individual ISAs is the difference in apnea hypopnea- index response, as measured by polysomnography, between tirzepatide and placebo arms at week 52. Secondary endpoints include sleep apnea-specific hypoxic burden, functional outcomes, and cardiometabolic biomarkers. The trial employs digital wearables, including home sleep testing to capture time to improvement and accelerometry for daily physical activity assessment, to evaluate exploratory outcomes.ConclusionSURMOUNT-OSA brings a novel design to investigate if tirzepatide provides clinically meaningful improvement in obesity-related OSA by targeting the underlying etiology.Trial registrationClinicalTrials.gov, NCT05412004.

Background & Aims Chronic obstructive pulmonary disease (COPD) is a debilitating respiratory disease and one of the main causes of death and disability in the world. Respiratory support treatments are among the methods for the recovery of these patients. The present study aims to assess the effect of breathing exercises and chest physiotherapy on the fatigue of patients with COPD. Materials & Methods This is a quasi-experimental study on 45 patients COPD who were selected by convenience sampling method and randomly assigned to two experimental groups of breathing exercises (n=15) and chest physiotherapy (n=15) and one control group (n=15). Before and 6 weeks after the intervention, Krupp’s Fatigue Severity Scale was completed by the patient. Data analysis was done using paired t-test, one-way analysis of variance and chi-square in SPSS software, version 26. Results The mean scores of fatigue severity were significantly different in all groups between pretest and post-test phases (P

Patients with chronic rhinosinusitis (CRS) report improved sleep quality after dupilumab, an anti IL4/13 therapy. Concurrent CRS and obstructive sleep apnea (OSA) cases are not rare, and CRS seemingly raises nasal resistance. Thus, we hypothesized that improved sleep quality by dupilumab therapy in CRS patients might be due to lowered nasal resistance and subsequent improvement of unrecognized comorbid OSA. Patients with concurrent CRS and OSA were recruited. Nasal resistance was measured invasively with transnasal pressure and flow data collected during normal respiration in the supine position. Results from the first five participants did not support our hypothesis. Subjective and objective measures for CRS and nasal resistance values were improved with dupilumab therapy in CRS patients with nasal polyps. However, apnea severity and sleep-related subjective parameters did not change. In the patients with CRS without nasal polyps, no significant changes in either CRS or OSA-related measures were observed.

Surgical interventions, like barbed reposition pharyngoplasty (BRP), are a valuable alternative for patients with obstructive sleep apnea (OSA) who are unable to tolerate continuous positive airway pressure (CPAP). However, predicting surgical success remains challenging, partly due to the contribution of non-anatomical factors. Therefore, combined medical treatment with acetazolamide, known to stabilize respiratory drive, may lead to superior surgical results. This double-blind, parallel-group randomized controlled trial evaluates the efficacy of acetazolamide as an add-on therapy to BRP in OSA. A total of 26 patients with moderate to severe OSA undergoing BRP were randomized to receive either acetazolamide or placebo post-surgery for 16 weeks. The group who was treated with BRP in combination with acetazolamide showed a reduction in AHI of 69.4%, significantly surpassing the 32.7% reduction of the BRP + placebo group (p < 0.01). The sleep apnea-specific hypoxic burden also decreased significantly in the group who was treated with BRP + acetazolamide (p < 0.01), but not in the group receiving BRP + placebo (p = 0.28). Based on these results, acetazolamide as an add-on therapy following BRP surgery shows promise in improving outcomes for OSA patients, addressing both anatomical and non-anatomical factors.

Background and Objective: We are witnessing a marked increase in demand for outpatient services. Patients experience health-related anxiety, which exerts destructive effects on the treatment. The control and management of this anxiety create confidence in health services. The present study aimed to determine the effect of nursing counseling on health anxiety and its relationship with trust in nursing services in the outpatient department. Materials and Methods: In this quasi-experimental study conducted in 2021, 60 participants were randomly selected from the outpatient department of a clinic and assigned to two groups: intervention and control. Data collection tools were a demographic information questionnaire, Alkovskis and Warwick Health Anxiety, and Trust in Nurses Scale (TNS) (Radwin and Cabral, 2010). The participants answered demographic and health anxiety questionnaires. After the visit, the intervention group received nursing counseling, while the control group only received routine training. One week later, the participants answered the health anxiety questionnaire and trust in nurses scale again. Data were analyzed in SPSS software (version 18) using descriptive and inferential statistical tests. Results: The mean of health anxiety before the consulting was not significantly different between the two groups (P=0.20); nonetheless, after the consulting, the intervention group obtained a lower mean score compared to the control group (P>0.001). There was a significant difference between this mean before and after consulting in the intervention group (P>0.001). There was a significant positive relationship between receiving nursing counseling and confidence in nursing services (P>0.001) (C.V=-0.145). Conclusion: As evidenced by the results of this study, the provision of nursing consultation reduces patients' health anxiety and increases confidence in nursing services. It is suggested to pay attention to this role of nurses in outpatient departments.

Background and Objectives: Chronic kidney disease is a debilitating disease that can also affect the family caregivers of patients. Increasing awareness and empowering caregivers can improve the physical and mental condition of patients and the resilience of caregivers. This study aims to evaluate the effect of an intervention based on the family-centered empowerment model (FCEM) on the resilience of family caregivers of hemodialysis patients. Methods: This is a randomized controlled clinical trial. Sixty family caregivers of patients in the hemodialysis department of Imam Khomeini Hospital in Kermanshah, Iran were selected by a random sampling method using a random number table. Then, they were randomly divided into two groups of intervention (n=30) and control (n=30). The assessment tools were a demographic form and the Connor-Davidson resilience scale. Descriptive and inferential statistics were used to analyze the data in SPSS software, version 18. Results: The results of independent t-test showed that the mean resilience score at baseline was not significantly different between the two groups (P=0.29). After the intervention, it was significantly increased in the intervention group compared to the control group (P

AimsApnoea-hypopnoea index (AHI), the universal clinical metric of sleep apnoea severity, poorly predicts the adverse outcomes of sleep apnoea, potentially because the AHI, a frequency measure, does not adequately capture disease burden. Therefore, we sought to evaluate whether quantifying the severity of sleep apnoea by the 'hypoxic burden' would predict mortality among adults aged 40 and older.Methods and resultsThe samples were derived from two cohort studies: The Outcomes of Sleep Disorders in Older Men (MrOS), which included 2743 men, age 76.3 ± 5.5 years; and the Sleep Heart Health Study (SHHS), which included 5111 middle-aged and older adults (52.8% women), age: 63.7 ± 10.9 years. The outcomes were all-cause and Cardiovascular disease (CVD)-related mortality. The hypoxic burden was determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline. Cox models were used to calculate the adjusted hazard ratios for hypoxic burden. Unlike the AHI, the hypoxic burden strongly predicted CVD mortality and all-cause mortality (only in MrOS). Individuals in the MrOS study with hypoxic burden in the highest two quintiles had hazard ratios of 1.81 [95% confidence interval (CI) 1.25-2.62] and 2.73 (95% CI 1.71-4.36), respectively. Similarly, the group in the SHHS with hypoxic burden in the highest quintile had a hazard ratio of 1.96 (95% CI 1.11-3.43).ConclusionThe 'hypoxic burden', an easily derived signal from overnight sleep study, predicts CVD mortality across populations. The findings suggest that not only the frequency but the depth and duration of sleep related upper airway obstructions, are important disease characterizing features.

The prevalence of obstructive sleep apnea (OSA) is on the rise, driven by various factors, including more sensitive diagnostic criteria, increased awareness, enhanced technology through at-home testing enabling easy and cost-effective diagnosis, and a growing incidence of comorbid conditions such as obesity. Treating symptomatic patients with OSA syndrome to enhance quality of life remains a cornerstone approach. However, there is a lack of consensus regarding treatment to improve cardiovascular disease (CVD) outcomes, particularly in light of overall negative results from several randomized controlled trials indicating no benefit of positive airway pressure therapy on primary and secondary CVD events. These randomized controlled trials were limited by suboptimal positive airway pressure adherence, use of composite CVD outcomes, and limited diversity and generalizability to sleep clinic patients. As such, this workshop assembled clinical experts, as well as researchers in basic and translational science, epidemiology, clinical trials, and population health, to discuss the current state and future research directions to guide personalized therapeutic strategies and future research directions in OSA. There was overall consensus among workshop participants that OSA represents a heterogeneous disease with variable endotypes and phenotypes and heterogeneous responses to treatment. Future research should prioritize using multimodal therapeutic approaches within innovative and adaptive trial designs, focusing on specific subgroups of patients with OSA hypothesized to benefit from a CVD perspective. Future work should also be inclusive of diverse populations and consider the life course of OSA to better comprehend treatment strategies that can address the disproportionate impact of OSA on racially minoritized groups. Furthermore, a more holistic approach to sleep must be adopted to include broader assessments of symptoms, sleep duration, and comorbid sleep and circadian disorders. Finally, it is imperative to establish a sleep research consortium dedicated to collecting raw data and biospecimens categorized by OSA subtypes. This will facilitate mechanistic determinations, foster collaborative research, and help bolster the pipeline of early-career researchers. [ABSTRACT FROM AUTHOR]

Objective: The efficacy of hypoglossal nerve stimulation (HGNS) therapy is limited by obstruction of the oropharyngeal lateral walls (OLWs). Our objective was to investigate the effect of palatine tonsillectomy on HGNS efficacy in obstructive sleep apnea (OSA) patients with OLW collapse. Study Design: Case‐control study of patients with moderate‐to‐severe OSA, complete‐or‐partial OLW collapse, and small tonsils (1 − 2+). Concomitant palatine tonsillectomy and HGNS (HGNS+T) were compared against a control group of patients who underwent HGNS alone. Setting: Single academic institution. Methods: Study outcomes were measures of HGNS efficacy defined as a %reduction in apnea‐hypopnea index (AHI) (primary) and successful treatment response (50% AHI reduction to <15/h, logistic regression), respectively. Regression analyses quantified the additional effect of tonsillectomy (HGNS+T vs HGNS alone, independent variable) on HGNS efficacy. Analyses were adjusted for OLW collapse severity (complete vs partial), tonsil size, age, sex, body mass index, and baseline AHI. Results: Nineteen patients underwent HGNS+T and had follow‐up sleep testing for the current analysis. The control group (HGNS alone) consisted of 78 patients. Baseline demographics and OSA severity were similar between the groups, except HGNS+T group had increased prevalence of complete OLW collapse. Linear regression demonstrated that adding tonsillectomy resulted in an additional 22.9% [7.5, 35.2] reduction in AHI [95% confidence interval, CI] (P =.006), and 8.6 [1.7,43.4] (P =.010) greater odds [95% CI] of a successful treatment response with HGNS. Conclusion: Compared to historically poorer outcomes of HGNS in patients with OLW collapse, these early results suggest combining tonsillectomy with HGNS may represent a promising strategy to improve success rates. [ABSTRACT FROM AUTHOR]

Background & Aims: Living with a temporary or permanent ostomy affects the quality of life (QoL) of people with an ostomy and requires increasing patients' self-efficacy to take care of themselves. Education is one way to improve individuals' QoL and self-care. Therefore, this study aimed to determine the effectiveness of distance self-care education on self-efficacy and QoL of patients with an intestinal ostomy in patients referred to Kermanshah hospitals in 2020-2021. Materials & Methods: In a quasi-experimental study before and after the process, 61 patients with intestinal ostomy referred to Imam Reza (AS), and Taleghani hospitals in Kermanshah province were selected from April to July 2021, using a simple sampling method. The samples first answered the self-efficacy questionnaires of ostomy patients and the quality of life of Weir and Sherborn. Then, the self-care program developed in the form of 8 45-minute group sessions was taught to patients by the researcher through discussion and conversation through a virtual network (WhatsApp), according to which they can use self-care at home, and two months after the end of the intervention. The mentioned questionnaires were distributed and completed among the patients again. Data were reported using SPSS software v. 20, and paired t-test and Wilcoxon tests were used for statistical analysis. Results: The Mean±SD of patients' QoL before the intervention was 34.05±16.53, reaching 49.63±21.59 after the intervention. Based on paired t-test, this difference was significant (P

A possible precision-medicine approach to treating obstructive sleep apnoea (OSA) involves targeting ventilatory instability (elevated loop gain) using supplemental inspired oxygen in selected patients. Here we test whether elevated loop gain and three key endophenotypic traits (collapsibility, compensation and arousability), quantified using clinical polysomnography, can predict the effect of supplemental oxygen on OSA severity.36 patients (apnoea-hypopnoea index (AHI) >20 events·h-1) completed two overnight polysomnographic studies (single-blinded randomised-controlled crossover) on supplemental oxygen (40% inspired) versus sham (air). OSA traits were quantified from the air-night polysomnography. Responders were defined by a ≥50% reduction in AHI (supine non-rapid eye movement). Secondary outcomes included blood pressure and self-reported sleep quality.Nine of 36 patients (25%) responded to supplemental oxygen (ΔAHI=72±5%). Elevated loop gain was not a significant univariate predictor of responder/non-responder status (primary analysis). In post hoc analysis, a logistic regression model based on elevated loop gain and other traits (better collapsibility and compensation; cross-validated) had 83% accuracy (89% before cross-validation); predicted responders exhibited an improvement in OSA severity (ΔAHI 59±6% versus 12±7% in predicted non-responders, p=0.0001) plus lowered morning blood pressure and "better" self-reported sleep.Patients whose OSA responds to supplemental oxygen can be identified by measuring their endophenotypic traits using diagnostic polysomnography.

Obstructive sleep apnea (OSA) is a common heritable disorder displaying marked sexual dimorphism in disease prevalence and progression. Previous genetic association studies have identified a few genetic loci associated with OSA and related quantitative traits, but they have only focused on single ethnic groups, and a large proportion of the heritability remains unexplained. The apnea-hypopnea index (AHI) is a commonly used quantitative measure characterizing OSA severity. Because OSA differs by sex, and the pathophysiology of obstructive events differ in rapid eye movement (REM) and non-REM (NREM) sleep, we hypothesized that additional genetic association signals would be identified by analyzing the NREM/REM-specific AHI and by conducting sex-specific analyses in multiethnic samples. We performed genome-wide association tests for up to 19,733 participants of African, Asian, European, and Hispanic/Latino American ancestry in 7 studies. We identified rs12936587 on chromosome 17 as a possible quantitative trait locus for NREM AHI in men (N = 6,737; P = 1.7 × 10-8) but not in women (P = 0.77). The association with NREM AHI was replicated in a physiological research study (N = 67; P = 0.047). This locus overlapping the RAI1 gene and encompassing genes PEMT1, SREBF1, and RASD1 was previously reported to be associated with coronary artery disease, lipid metabolism, and implicated in Potocki-Lupski syndrome and Smith-Magenis syndrome, which are characterized by abnormal sleep phenotypes. We also identified gene-by-sex interactions in suggestive association regions, suggesting that genetic variants for AHI appear to vary by sex, consistent with the clinical observations of strong sexual dimorphism.

Surgical interventions, like barbed reposition pharyngoplasty (BRP), are a valuable alternative for patients with obstructive sleep apnea (OSA) who are unable to tolerate continuous positive airway pressure (CPAP). However, predicting surgical success remains challenging, partly due to the contribution of non-anatomical factors. Therefore, combined medical treatment with acetazolamide, known to stabilize respiratory drive, may lead to superior surgical results. This double-blind, parallel-group randomized controlled trial evaluates the efficacy of acetazolamide as an add-on therapy to BRP in OSA. A total of 26 patients with moderate to severe OSA undergoing BRP were randomized to receive either acetazolamide or placebo post-surgery for 16 weeks. The group who was treated with BRP in combination with acetazolamide showed a reduction in AHI of 69.4%, significantly surpassing the 32.7% reduction of the BRP + placebo group (p < 0.01). The sleep apnea-specific hypoxic burden also decreased significantly in the group who was treated with BRP + acetazolamide (p < 0.01), but not in the group receiving BRP + placebo (p = 0.28). Based on these results, acetazolamide as an add-on therapy following BRP surgery shows promise in improving outcomes for OSA patients, addressing both anatomical and non-anatomical factors. [ABSTRACT FROM AUTHOR]

Rationale: Moderate-severe obstructive sleep apnea (OSA) (apnea–hypopnea index [AHI], >15 events/h) disturbs sleep through frequent bouts of apnea and is associated with daytime sleepiness. However, many individuals without moderate-severe OSA (i.e., AHI <15 events/h) also report sleepiness. Objectives: To test the hypothesis that sleepiness in the AHI <15 events/h group is a consequence of substantial flow limitation in the absence of overt reductions in airflow (i.e., apnea/hypopnea). Methods: A total of 1,886 participants from the MESA sleep cohort were analyzed for frequency of flow limitation from polysomnogram-recorded nasal airflow signal. Excessive daytime sleepiness (EDS) was defined by an Epworth Sleepiness Scale score ⩾11. Covariate-adjusted logistic regression assessed the association between EDS (binary dependent variable) and frequency of flow limitation (continuous) in individuals with an AHI <15 events/h. Results: A total of 772 individuals with an AHI <15 events/h were included in the primary analysis. Flow limitation was associated with EDS (odds ratio, 2.04; 95% confidence interval, 1.17–3.54; per 2–standard deviation increase in flow limitation frequency) after adjusting for age, sex, body mass index, race/ethnicity, and sleep duration. This effect size did not appreciably change after also adjusting for AHI. Conclusions: In individuals with an AHI <15 events/h, increasing flow limitation frequency by 2 standard deviations is associated with a twofold increase in the risk of EDS. Future studies should investigate addressing flow limitation in low-AHI individuals as a potential mechanism for ameliorating sleepiness. [ABSTRACT FROM AUTHOR]