Sleep drug could quiet breathing pauses in apnea

NCT ID NCT07683442

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial investigates whether lemborexant, a sleep medication, can reduce the number of breathing pauses in adults with moderate obstructive sleep apnea who have a low arousal threshold (wake up easily). Participants take either lemborexant or a placebo daily for 30 days in three separate phases. The main goal is to see if the drug lowers the apnea-hypopnea index (AHI), a measure of breathing interruptions during sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lemborexant (Dayvigo)
What this could lead to
If it works, lemborexant could offer a new medication option for people with moderate sleep apnea who wake up too easily during sleep.
What could go wrong
This is an early-phase trial with only 36 participants, so results may not apply to everyone. The drug may not improve apnea enough to be clinically meaningful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria Individuals are eligible for participation in this study if they have all of the followings: 1. Patient, aged 18 - 65 years at the time of informed consent 2. Voluntary agreement and capable for giving written informed consent 3. Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision 4. Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events/h of sleep (moderate severity) 5. 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. 6. Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit 7. Habitually sleeping ≥ 5.5 hours/night with usual bedtime falls within the range of 9:00 PM to 1:00 AM 8. 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: 1. Previous allergy or adverse effects with Lemborexant or other sedatives 2. Pregnant or breastfeeding 3. Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion 4. Uncontrolled cardiovascular or cerebrovascular diseases 5. Neuromuscular diseases 6. Nasal anatomical defect 7. Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion 8. Active respiratory disorders other than OSA 9. Central respiratory events (CAHI) \>25% of the total AHI 10. Diagnosis/symptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder 11. Severe hypersomnolence (ESS ≥16) 12. Peripheral capillary oxygen saturation (SpO2) \< 80% for ≥ 5% of total sleep time measured during screening visit 13. Driving-related sleepiness accident or near misses in the past 12 months 14. Safety-critical occupation 15. Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study 16. Unable to tolerate equipment in this study 17. Taking any medication that affects sleep or other variable measured in this study 18. Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers 19. Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake 20. Excessive caffeine intake

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Chulalongkorn University

    Pathum Wan, Bangkok, 10330, Thailand

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