A Randomized, Double-blind, Placebo-Controlled Trial on the Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold

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The goal of this randomized, placebo-controlled, double-blind, crossover trial (1-week wash out period) is to compare 1 night of 5 mg Lemborexant to placebo administered before sleep in 20 moderate to severe OSA patients with low arousal threshold The main questions it aims to answer are: 1. The effect of Lemborexant on apnea/hypopnea index (AHI) in moderate-to-severe OSA patients with low arousal threshold. 2. The effect of Lemborexant on the following parameters in moderate-to-severe OSA patients with low arousal threshold. * Arousal threshold * Mean and nadir oxygen saturation * Sleep latency * Sleep efficiency * Wake after sleep onset (WASO) * Percentage of time spent in NREM stage 1-3 and REM stage * Stanford Sleepiness Scale Questionnaire in the morning * The Oxford Sleep Resistance Test (OSLER) test Participants will * complete two overnight in-laboratory polysomnography (1-week washout), with esophageal pressure catheter placement and standard polysomnography monitoring * complete the Stanford Sleepiness Scale Questionnaire and OSLER test in the morning of the two overnight test Researchers will compare with the placebo group to see if there is a difference in AHI

2023-02-01

2025-05-01

2025-05-01

Recruiting

Early phase I

20

Inclusion Criteria: * Untreated OSA patient 18 - 65 years of age(49) * AHI ≥15 events/h of sleep (moderate to severe)(23, 49) * Low arousal threshold was defined using previously recommended criteria which allocated a score of 1 to each criterion that was satisfied: (apnea-hypopnea index, \<30 events per hour) + (nadir oxygen saturation as measured by pulse oximetry \>82.5%) + (fraction of hypopneas \>58.3%). A score of 2 or above defined a low arousal threshold(50) (low arousal threshold defined as esophageal pressure values are 0 to -15 cmH2O)(27) Exclusion Criteria: * Previous allergy or adverse effects with Lemborexant or other sedatives - Taking any medication that affects sleep or other variable measured in this study - Pregnant or nursing mothers - Respiratory disorders other than OSA - Comorbid disease of poor controlled or resistant hypertension, uncontrolled cardiovascular or cerebrovascular disease * Using CPAP or other dental devices * Unable to tolerate equipment in this study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The patients will be subsequently randomized 1:1 to one of the two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period. Patients will receive either Lemborexant 5 mg per day or placebo prior 5 minutes before lights-out. Time of lights out was calculated from the median usual bedtime for each participant from the most recent 5 days (± 1 hour) and was kept constant between the two study nights. During this 2-night polysomnography, sleep parameters will be analyzed. The Stanford Sleepiness Scale Questionnaire to define sleepiness and OSLER test to define vigilance will be obtained on the following morning.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-02-13