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

NCT07683442 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 0594/69
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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:

• 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
• Oxford Sleep Resistance Test (OSLER) test
• Epworth Sleepiness Scale (ESS)
• Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
• Pittsburgh Sleep Quality Index (PSQI)
• Actigraphy parameters
• Total sleep time
• Sleep efficiency
• Wake after sleep onset (WASO)
• Sleep latency
• 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

Conditions

OSA - Obstructive Sleep Apnea

Keywords

Apnea/Hypopnea Index (AHI); Lemborexant; Obstructive Sleep Apnea (OSA); Low Arousal Threshold; Polysomnography

Outcome Measures

Primary Outcomes (1)

• Apnea/hypopnea index (AHI)

  Apnea/hypopnea index (AHI) measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)

  At day 30 during the overnight in-laboratory of each study period

Secondary Outcomes (20)

• Mean and nadir oxygen saturation

  At day 30 during the overnight in-laboratory of each study period

• Sleep efficiency

  At day 30 during the overnight in-laboratory of each study period

• Wake after sleep onset (WASO)

  At day 30 during the overnight in-laboratory of each study period

• Sleep latency

  At day 30 during the overnight in-laboratory of each study period

• REM latency

  At day 30 during the overnight in-laboratory of each study period

Study Arms (3)

Lemborexant 5 mg

EXPERIMENTAL

Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 5 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 5 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 10 mg arm with same repeat of another 2 phases.

Drug: Lemborexant 5 MG [Dayvigo] Period 1; Drug: Lemborexant 5 MG [Dayvigo] Period 2; Drug: Lemborexant 5 MG [Dayvigo] Period 3

Placebo

PLACEBO COMPARATOR

Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive placebo per day before sleep for a total of 30 days. On the day 30 participants will receive the placebo 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the lemborexant 5 or 10 mg arm with same repeat of another 2 phases.

Drug: Placebo Period 1; Drug: Placebo Period 2; Drug: Placebo Period 3

Lemborexant 10 mg

EXPERIMENTAL

Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 10 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 10 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 5 mg arm with same repeat of another 2 phases.

Drug: Lemborexant 10 MG [Dayvigo] Period 1; Drug: Lemborexant 10 MG [Dayvigo] Period 2; Drug: Lemborexant 10 MG [Dayvigo] Period 3

Interventions

Lemborexant 5 MG [Dayvigo] Period 1 DRUG

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

Lemborexant 5 mg

Placebo Period 1 DRUG

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

Placebo

Lemborexant 5 MG [Dayvigo] Period 2 DRUG

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

Lemborexant 5 mg

Placebo Period 2 DRUG

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

Placebo

Lemborexant 5 MG [Dayvigo] Period 3 DRUG

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

Lemborexant 5 mg

Placebo Period 3 DRUG

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

Placebo

Lemborexant 10 MG [Dayvigo] Period 1 DRUG

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

Lemborexant 10 mg

Lemborexant 10 MG [Dayvigo] Period 2 DRUG

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

Lemborexant 10 mg

Lemborexant 10 MG [Dayvigo] Period 3 DRUG

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

Lemborexant 10 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarocha Vivatvakin, MD

  Department of Medicine, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarocha Vivatvakin, MD

CONTACT

66879310233; sarocha.v@chula.ac.th

Naricha Chirakalwasan, MD

CONTACT

662-649-4037; narichac@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)