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NOT YET RECRUITING
NCT07683442
PHASE1/PHASE2

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

Sponsor: Chulalongkorn University

View on ClinicalTrials.gov

Summary

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

Official title: One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-09-01

Completion Date

2028-06-30

Last Updated

2026-07-06

Healthy Volunteers

No

Conditions

OSA - Obstructive Sleep Apnea

Interventions

DRUG

Lemborexant 5 MG [Dayvigo] Period 1

Participants will receive lemborexant 5 mg per day for 30 days during first period

DRUG

Placebo Period 1

Participants will receive placebo 5 mg per day for 30 days during the first period

DRUG

Lemborexant 5 MG [Dayvigo] Period 2

Participant will receive lemborexant 5 mg per day for 30 days during the second period

DRUG

Placebo Period 2

Participant will receive placebo 5 mg per day for 30 days during the second period

DRUG

Lemborexant 5 MG [Dayvigo] Period 3

Participants will receive lemborexant 5 mg per day for 30 days during third period

DRUG

Placebo Period 3

Participants will receive placebo per day for 30 days during third period

DRUG

Lemborexant 10 MG [Dayvigo] Period 1

Participants will receive lemborexant 10 mg per day for 30 days during first period

DRUG

Lemborexant 10 MG [Dayvigo] Period 2

Participants will receive lemborexant 10 mg per day for 30 days during second period

DRUG

Lemborexant 10 MG [Dayvigo] Period 3

Participants will receive lemborexant 10 mg per day for 30 days during third period

Locations (1)

Chulalongkorn University

Pathum Wan, Bangkok, Thailand