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Not yet recruitingPhase 1/2

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

Key facts

Who runs it
Chulalongkorn University
Where
Thailand1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
Phase
Phase 1/2
People taking part
36 people, planned
Started
1 Sept 2026
Expected to end
30 Jun 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Lemborexant 5 MG [Dayvigo] Period 1
  • Placebo Period 1
  • Lemborexant 5 MG [Dayvigo] Period 2
  • Placebo Period 2
  • Lemborexant 5 MG [Dayvigo] Period 3
  • Placebo Period 3
  • Lemborexant 10 MG [Dayvigo] Period 1
  • Lemborexant 10 MG [Dayvigo] Period 2
  • Lemborexant 10 MG [Dayvigo] Period 3
Record updated
6 July 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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
  • Unable to tolerate equipment in this study
  • Taking any medication that affects sleep or other variable measured in this study
  • Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers
  • Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake
  • Excessive caffeine intake

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 3 groups in the trial

  • Lemborexant 5 mgTreatment being tested

    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.

    Treatment: Lemborexant 5 MG [Dayvigo] Period 1, Lemborexant 5 MG [Dayvigo] Period 2, and Lemborexant 5 MG [Dayvigo] Period 3

  • PlaceboPlacebo, for comparison

    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.

    Treatment: Placebo Period 1, Placebo Period 2, and Placebo Period 3

  • Lemborexant 10 mgTreatment being tested

    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.

    Treatment: Lemborexant 10 MG [Dayvigo] Period 1, Lemborexant 10 MG [Dayvigo] Period 2, and Lemborexant 10 MG [Dayvigo] Period 3

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT07683442, who can take part
Record updated
6 July 2026