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Could a common sleep drug ease sleep apnea? small trial hints at possibility

NCT ID NCT05763329

Symptom relief Sponsor: Chulalongkorn University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This small study tested whether the sleep medication lemborexant (Dayvigo) can help people with moderate-to-severe obstructive sleep apnea (OSA) who have a low arousal threshold—meaning they wake up easily during sleep. Ten untreated adults each took the drug or a placebo on two separate nights in a sleep lab. Researchers measured breathing pauses, oxygen levels, and sleep quality to see if lemborexant could improve sleep without making apnea worse.

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) 5 mg oral tablet
What this could lead to
If it works, this could point toward a new way to treat sleep apnea by helping people stay asleep without worsening breathing pauses.
What could go wrong
This is a very small, early-phase trial with only 10 people, so results may not apply widely. The drug could also cause daytime sleepiness or other side effects.

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

10 people

The number who actually took part.

Started

Feb 2023

Finished

Jun 2025

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: * Untreated OSA patient 18 - 65 years of age(49) * AHI ≥15 events/h of sleep (moderate to severe)(23, 49) * Low arousal threshold was defined using previously recommended criteria which allocated a score of 1 to each criterion that was satisfied: (apnea-hypopnea index, \<30 events per hour) + (nadir oxygen saturation as measured by pulse oximetry \>82.5%) + (fraction of hypopneas \>58.3%). A score of 2 or above defined a low arousal threshold(50) (low arousal threshold defined as esophageal pressure values are 0 to -15 cmH2O)(27) Exclusion Criteria: * Previous allergy or adverse effects with Lemborexant or other sedatives - Taking any medication that affects sleep or other variable measured in this study - Pregnant or nursing mothers - Respiratory disorders other than OSA - Comorbid disease of poor controlled or resistant hypertension, uncontrolled cardiovascular or cerebrovascular disease * Using CPAP or other dental devices * Unable to tolerate equipment in this study

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Conditions

The condition(s) this trial relates to.

Apnea obstructive sleep apnea syndrome

As listed by the trial registrant

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

OSA

Contacts and locations

Locations

  • Chulalongkorn University

    Pathum Wan, Bangkok, 10330, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.