The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: OSA - Obstructive Sleep Apnea

In brief

The goal of this clinical trial is to investigate the 1-month treatment effects of different dose of lemborexant in moderate OSA adult patients (18-65 years of age) with low arousal threshold. The main questions it aims to answer are: Primary outcome measure: Apnea/hypopnea index (AHI) Secondary outcome measure: 1. Polysomnography parameters * Mean and nadir oxygen saturation * Sleep efficiency * Wake after sleep onset (WASO) * Sleep latency * Rapid eye movement (REM) latency * Percentage of time spent in Non-rapid eye movement (NREM) stage 1-3 and REM stage * Arousal index 2. Oxford Sleep Resistance Test (OSLER) test 3. Epworth Sleepiness Scale (ESS) 4. Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) 5. Pittsburgh Sleep Quality Index (PSQI) 6. Actigraphy parameters * Total sleep time * Sleep efficiency * Wake after sleep onset (WASO) * Sleep latency 7. Sleep diary parameters (Appendix 5) * Total sleep time * Sleep efficiency * Wake after sleep onset (WASO) * Sleep latency * Sleep quality Researchers will compare placebo to see if there is a difference in AHI. Participants will * participate a total of 3 phases of study (3-crossover trial) * each phrase the participants will receive either lemborexant 5 mg, lemborexant 10 mg, or placebo orally per day for 30 days with 2-week washout (depend on intervention arm whether the participants receive which intervention sequence) * complete three overnight in-laboratory polysomnography (2-week washout) at day 30 of each phrase * monitor actigraphy during day 1 to 29 of intervention of all periods * record sleep diary during day 1 to 29 of intervention of all periods * complete the OSLER test in the morning of the three overnight test * complete questionnaires including: Epworth Sleepiness Scale (ESS), Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T), Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention) and the night before overnight in-laboratory polysomnography

Key facts

Study ID

NCT07683442

Run by

Chulalongkorn University

People needed

36

Starts

2026-09-01

Expected to finish

2028-06-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals are eligible for participation in this study if they have all of the followings:
• Patient, aged 18 - 65 years at the time of informed consent
• Voluntary agreement and capable for giving written informed consent
• Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision
• Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events/h of sleep (moderate severity)
• Patients identified as low arousal threshold using previously recommended criteria which allocated a score of 1 to each criterion: apnea-hypopnea index < 30 events per hour, nadir oxygen saturation as measured by pulse oximetry > 82.5%, and fraction of hypopneas > 58.3%. A score of 2 or above defined a low arousal threshold.
• Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit
• Habitually sleeping ≥ 5.5 hours/night with usual bedtime falls within the range of 9:00 PM to 1:00 AM
• Body mass index 18 - 40 kg/m2 Exclusion criteria
• Individuals were not eligible for participation in this study if they have any of the followings:
• Previous allergy or adverse effects with Lemborexant or other sedatives
• Pregnant or breastfeeding
• Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
• Uncontrolled cardiovascular or cerebrovascular diseases
• Neuromuscular diseases
• Nasal anatomical defect
• Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
• Active respiratory disorders other than OSA
• Central respiratory events (CAHI) >25% of the total AHI
• Diagnosis/symptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder
• Severe hypersomnolence (ESS ≥16)
• Peripheral capillary oxygen saturation (SpO2) < 80% for ≥ 5% of total sleep time measured during screening visit
• Driving-related sleepiness accident or near misses in the past 12 months
• Safety-critical occupation
• Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study

Where it is running

• Chulalongkorn University — Pathum Wan, Bangkok, Thailand

Full record on ClinicalTrials.gov

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