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Importance: Drug-induced sleep endoscopy (DISE) is used to guide therapeutic management of obstructive sleep apnea (OSA), depending on the levels and patterns of pharyngeal collapse. However, the collapsibility of specific pharyngeal sites remains unknown., Objective: To assess collapse sites in patients with OSA undergoing DISE and whether number and location are associated with differences in airway collapsibility; and to quantify differences in collapsibility between primary and secondary sites in multilevel collapse., Design, Setting, and Participants: This cohort study assessed adult patients (≥18 years) with OSA undergoing DISE with manometry and positive airway pressure (PAP) titration at a tertiary care center from November 2021 to November 2023. Patients with an AHI score greater than 5 were included; those with less than 1 apnea event during DISE or incorrect catheter placement were excluded. Data were analyzed from September 28, 2022, to March 31, 2024., Exposure: DISE with manometry and PAP titration., Main Outcomes and Measures: Active pharyngeal critical pressure (Pcrit-A) and pharyngeal opening pressure (PhOP) were used to quantify airway collapsibility, adjusted for covariates (age, sex, race, and body mass index [BMI])., Results: Of 94 screened, 66 patients (mean [SD] age, 57.4 [14.3] years; BMI, 29.2 [3.9]; 51 [77.3%] males) with a mean (SD) apnea-hypopnea index (AHI) of 31.6 (19.0) were included in the analysis. Forty-seven patients (71.2%) had multilevel collapse, 10 (15.2%) had single-level nasopalatal collapse, and 9 (13.6%) had single-level infrapalatal collapse. Groups did not differ in demographic characteristics or established measures of OSA severity. The single-level nasopalatal group had substantially elevated levels of airway collapsibility (Pcrit-A and PhOP covariate adjusted mean, 2.4; 95% CI, 1.1 to 3.8; and 8.2; 95% CI, 6.4 to 9.9 cmH2O) compared to the single-level infrapalatal group (-0.9; 95% CI, -2.4 to 0.5 cmH2O; and 4.9; 95% CI, 3.0 to 6.8 cmH2O, respectively) and similar to the level among the multilevel group (1.3; 95% CI, 0.7 to 2.0; and 8.5; 95% CI, 7.7 to 9.3 cmH2O). The multilevel group had more negative inspiratory pressure (-24.2; 95% CI, -28.1 to -20.2 cmH2O) compared to the single-level nasopalatal group (-9.8; 95% CI, -18.3 to -1.28 cmH2O). In patients with multilevel collapse, airway collapsibility was significantly higher at the primary nasopalatal compared to secondary infrapalatal site (mean difference, 13.7; 95% CI, 11.3 to 16.1 cmH2O)., Conclusions and Relevance: The findings of this cohort study suggest that intervention should target the primary site of pharyngeal collapse, and secondary sites only if they are nearly as collapsible as the primary site. Future work is needed to precisely define the difference in primary and secondary collapsibility that necessitates multilevel treatment.

Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA)., Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA., Design, Setting, and Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023., Intervention: Implant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively., Main Outcomes and Measures: Primary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale)., Results: Among 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol., Conclusions and Relevance: This randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI., Trial Registration: ClinicalTrials.gov Identifier: NCT02263859.

Importance: Recent retrospective hypoglossal nerve stimulation (HGNS) outcomes data suggest that patients with low therapeutic positive airway pressure (PAP) levels achieve greater success than patients with high therapeutic PAP levels., Objective: To examine the use of therapeutic nasal PAP levels at the soft palate in predicting the outcomes of HGNS for patients with obstructive sleep apnea., Design, Setting, and Participants: This prospective cohort study used drug-induced sleep endoscopy (DISE) to evaluate the predictive capacity of therapeutic PAP levels in HGNS outcomes. In an academic sleep surgery center, 27 consecutive patients with obstructive sleep apnea who underwent DISE before implantation of an HGNS device were evaluated. The study was conducted from May 1, 2018, to June 26, 2019., Exposures: Positive airway pressure delivered through a nasal mask during DISE., Main Outcomes and Measures: Improvement in apnea-hypopnea index as measured from full-night preoperative and postoperative efficacy studies., Results: Twenty-seven patients met all inclusion criteria. The mean (SD) age was 62.0 (14.4) years, 14 participants were men (51.9%), and mean body mass index was 28.1 (4.0). Responders to HGNS therapy (n = 18) had significantly lower mean (SD) palatal opening pressure compared with nonresponders (n = 9) (5.0 [2.8] vs 9.2 [3.7] cm H2O, respectively; mean difference, -4.2; 95% CI, -6.8 to -1.6 cm H2O). After adjusting for age, sex, and body mass index, the mean palatal opening pressure value for the responders remained 3.5 cm H2O lower (95% CI, -6.7 to -0.4 cm H2O) than that of nonresponders. A palatal opening pressure cutoff level less than 8 cm H2O demonstrated a positive predictive value of 82.4%; sensitivity, 77.8%; and specificity, 66.7%., Conclusions and Relevance: In this small prospective cohort study, therapeutic nasal PAP levels during DISE differed significantly between responder and nonresponders to HGNS. Because DISE represents a mandatory, relatively standardized diagnostic tool for HGNS candidacy, the use of therapeutic nasal PAP through DISE can be broadly implemented and studied across multiple centers to possibly improve patient selection for HGNS.

Background: Hypoglossal nerve stimulation has been demonstrated to relieve upper airway obstruction acutely, but its effect on obstructive sleep apnea is not known., Objective: To determine the response in obstructive sleep apnea to electrical stimulation of the hypoglossal nerve., Methods: Eight patients with obstructive sleep apnea were implanted with a device that stimulated the hypoglossal nerve unilaterally during inspiration. Sleep and breathing patterns were examined at baseline before implantation and after implantation at 1, 3, and 6 months and last follow-up., Results: Unilateral hypoglossal nerve stimulation decreased the severity of obstructive sleep apnea throughout the entire study period. Specifically, stimulation significantly reduced the mean apnea-hypopnea indices in non-rapid eye movement (mean +/- SD episodes per hour, 52.0 +/- 20.4 for baseline nights and 22.6 +/- 12.1 for stimulation nights; P<.001) and rapid eye movement (48.2 +/- 30.5 and 16.6 +/- 17.1, respectively; P<.001) sleep and reduced the severity of oxyhemoglobin desaturations. With improvement in sleep apnea, a trend toward deeper stages of non-rapid eye movement sleep was observed. Moreover, all patients tolerated long-term stimulation at night and did not experience any adverse effects from stimulation. Even after completing the study protocol, the 3 patients who remained free from stimulator malfunction continued to use this device as primary treatment., Conclusion: The findings demonstrate the feasibility and therapeutic potential for hypoglossal nerve stimulation in obstructive sleep apnea.

Objective: To evaluate the effect of selective electrical stimulation of the tensor veli palatini muscle on upper airway patency., Methods: Pressure-flow relationships were evaluated, in a feline isolated upper airway preparation, to determine the role of the soft palate musculature on airflow dynamics. The tensor veli palatini muscles were selectively stimulated while monitoring upper airway collapsibility (critical pressure), maximal inspiratory airflow, and the nasal resistance upstream to the flow-limiting site., Results: Tensor veli palatini stimulation resulted (mean +/- SEM) in an increase in maximal inspiratory airflow from 74 +/- 13 mL/s to 93 +/- 18 mL/s (P= .04). The increase in maximal inspiratory airflow was associated with a decrease in critical pressure from -2.3 +/- 1.7 cm H2O to -4.7 +/- 2.7 cm H2O (P= .01) and an increase in nasal resistance from 32.4 +/- 24.3 cm H2O x L(-1) s(-1) to 50.8 +/- 29.7 cm H2O x L(-1) s(-1) (P= .02)., Conclusions: Tensor veli palatini stimulation decreases upper airway collapsibility and is likely an integral component in maintaining airway patency. However, the effects of the isolated tensor veli palatini muscles are less significant than those seen previously with physiologic stimuli such as hypercapnia. These findings suggest that upper airway patency, although contributed to by the tensor veli palatini, requires the coordinated activation of palatopharyngeal muscles to adequately influence upper airway collapsibility.

Objective: To determine the effect of tracheotomy on polysomnographic and arterial blood gas data in patients with obstructive sleep apnea (OSA)., Design: A retrospective study of all patients who underwent tracheotomy and were studied polysomnographically at the Johns Hopkins Sleep Disorders Center, Baltimore, Md, since 1981., Setting: A regional sleep disorders center., Patients: Twenty-eight patients (8 women and 20 men), aged 22 through 77 years. Patients were categorized into 2 groups on the basis of whether they had already undergone tracheotomy before polysomnography. Group 1 patients all had a polysomnographic diagnosis of OSA before tracheotomy. They were further subdivided on the basis of whether cardiopulmonary decompensation had been absent (group 1a, n=10) or present (group 1b, n=13). Group 2 patients (n=5) had undergone tracheotomy to treat upper airway obstruction that developed after non-apnea-related upper aerodigestive tract surgeries., Intervention: Tracheotomy., Main Outcome Measures: Nocturnal non-rapid eye movement, apnea-hypopnea index, percentage oxyhemoglobin saturation, and arterial blood gas data., Results: Patients with OSA underwent tracheotomy as definitive treatment for the apnea (n=15), to prevent postoperative upper airway compromise after uvulopalatopharyngoplasty (n=7), and to treat upper airway compromise after non-apnea-related upper aerodigestive tract surgeries (n=6). Tracheotomy alleviated apnea in all 10 patients with uncomplicated sleep apnea (group 1a). For patients with OSA complicated by cardiopulmonary decompensation (group 1b), tracheotomy improved but did not eliminate sleep apnea in 7 of the 13 patients, despite overall improvement in arterial blood gas values. For patients whose sleep apnea had not been diagnosed polysomnographically before tracheotomy (group 2), tracheotomy was still required to treat OSA that had previously not been recognized., Conclusions: Tracheotomy effectively treated patients with uncomplicated OSA, but was much less effective in treating patients with OSA and cardiopulmonary decompensation. In patients who underwent tracheotomy in conjunction with other upper aerodigestive tract surgeries, concomitant obstructive sleep apnea often required continued use of a tracheotomy to maintain upper airway patency.

Objectives: To determine the motor responses resulting from direct electrical stimulation of the hypoglossal (HG) nerve and to correlate these responses to changes in upper airway patency during sleep., Design: The motor effects of direct electrical stimulation of the main trunk of the HG nerve and the branch that supplies the genioglossus muscle during anesthesia and wakefulness were assessed visually. Responses in airflow during sleep to HG nerve stimulation were assessed with standard polysomnographic techniques., Setting: University medical center., Patients: Fifteen patients undergoing a surgical procedure that involved the neck that exposed the HG nerve and 5 volunteer patients with obstructive sleep apnea constituted the study population., Interventions: The main trunk (n = 3) and genioglossus branch (n = 2) of the HG nerve were stimulated electrically with a half-cuff tripolar electrode., Results: Stimulation of the branch of the HG nerve that innervates the genioglossus muscle caused protrusion and contralateral deviation of the tongue. Stimulation of the main trunk of the HG nerve caused slight ipsilateral deviation and retrusion of the tongue. The arousal threshold for stimulation exceeded the motor recruitment threshold by 0.8 +/- 0.4 V. Inspiratory airflow increased in all patients by 184.5 +/- 61.7 mL/s (mean +/- SD; P = .02, analysis of variance) with stimulation., Conclusion: Direct HG nerve stimulation below the arousal threshold can improve airflow in patients with obstructive sleep apnea.

Objective: To evaluate the effect of electrical stimulation of hypoglossal nerve branches and ansa cervicalis nerve branches on upper airway patency., Design: Pressure-flow relationships obtained during supramaximal stimulation of hypoglossal nerve branches and ansa cervicalis nerve branches were analyzed in the isolated feline upper airway to determine the maximum inspiratory airflow as well as to determine pharyngeal collapsibility (upper airway critical pressure) and nasal resistance upstream from the site of pharyngeal collapse. Comparisons were performed between baseline and stimulation conditions with paired two-tailed t tests., Results: Stimulation of the proximal hypoglossal nerve trunk, distal medial hypoglossal nerve branch, nerve branches to the suprahyoid muscles, the infrahyoid muscles, and the suprahyoid and infrahyoid muscles simultaneously increased maximum inspiratory airflow significantly by decreasing airway collapsibility. A greater reduction in airway collapsibility was observed with stimulation of the tongue muscles compared with stimulation of the strap muscles., Conclusions: Stimulation of specific hypoglossal and ansa cervicalis nerve branches consistently increased maximum inspiratory airflow by decreasing airway collapsibility. The major decrease in airway collapsibility from hypoglossal nerve stimulation is dependent on the action of the genioglossus muscle.