Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

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.

Oral Appliances for Snoring and Obstructive Sleep Apnea.

Obstructive sleep apnea is a common condition, caused primarily by narrowing of the nasal and pharyngeal airway, leading to partial or complete airway collapse during sleep. Treatment with positive airway pressure (PAP) is considered first-line therapy, due to an efficacy rate of approximately 95%, yet long-term compliance with PAP is less than 40%. The efficacy of a sleep oral appliance is lower than PAP, yet it may have similar effectiveness. A sleep oral appliance is a reasonable second-line therapy for patients who refuse or fail PAP and may be reasonable first-line therapy.

Nasal Surgery for Obstructive Sleep Apnea Syndrome.

Obstructive sleep apnea is a common condition, primarily caused by narrowing of the nasal and pharyngeal airway. Treatment with continuous positive airway pressure (CPAP) is considered the first line of therapy, but long-term compliance is only about 40%, often because of nasal obstruction. Any nasal obstruction can worsen CPAP compliance. Treatment of the nasal obstruction with topical nasal steroid sprays or nasal dilators has been shown to improve sleep disordered breathing. Surgical treatment of nasal obstruction, has been shown to improve sleep disordered breathing, as well as CPAP requirement and compliance with CPAP.

Anesthetic and postoperative management of the obstructive sleep apnea patient.

Sleep apnea patients pose a challenge for surgeons, anesthesiologists, and surgical facilities as there is increased risk for anesthetic and postoperative complications. Precautions before and after surgery minimize these risks. Screening for sleep apnea should be done for all surgical patients. Safe perioperative management requires judicious use of narcotics and sedating medications, reducing upper airway edema, prevention of aspiration and deep vein thrombosis, blood pressure control, use of positive airway pressure, and proper postoperative monitoring. Although the literature lacks specific recommendations, the guidelines presented in this article are based on more than 20 years of experience and supported by peer-reviewed medical literature.

Preoperative and postoperative management of obstructive sleep apnea patients.

Safe perioperative management of patients with obstructive sleep apnea (OSA) requires special attention to preoperative and postoperative care. Patients with OSA are more likely to have comorbidities including hypertension, esophageal and laryngopharyngeal reflux disease, coronary artery disease, and obesity. Obesity may also contribute to deep vein thrombosis and pulmonary emboli. OSA increases the risk for anesthetic and postoperative complications. The recommendations for measures for preoperative and postoperative management of OSA presented in this article are based on a culmination of 20 years experience supported by the peer-reviewed medical literature.