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Can a High-Tech Eye-Mask help you sleep better and use your CPAP more?

NCT ID NCT07521319

Symptom relief Sponsor: National Sun Yat-sen 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 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.
Paused
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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a wearable smart eye-mask that combines gentle heat and massage with voice-guided sleep therapy to help people who have both insomnia and sleep apnea. The 4-year project will first explore how the condition works, then develop the device, and finally test it in 160 people across multiple centers. Researchers hope the approach will reduce insomnia symptoms and improve how often people use their CPAP machines.

What this could mean

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

Active substance
Brief Behavioral Therapy for Insomnia (BBTi) and a smart eye-mask device
What this could lead to
If it works, this could offer a convenient, drug-free way to improve sleep and help people stick with their CPAP therapy.
What could go wrong
This is an early-stage trial with multiple phases, so results are uncertain. The device and therapy may not work for everyone, and the study hasn't started recruiting yet.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 361 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

20 to 80 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: * Age ≥20 years. * Obstructive sleep apnea (OSA) diagnosed by clinical polysomnography (PSG), defined as apnea-hypopnea index (AHI) ≥5 events/hour. * Insomnia disorder diagnosed by a physician according to DSM-5 criteria, with Insomnia Severity Index (ISI) score ≥15. * Able to understand study procedures and provide written informed consent. Exclusion Criteria: * Severe cognitive impairment, * Major psychiatric disorder, * Severe chronic illness (e.g., severe heart failure or receiving hemodialysis). * Other sleep disorders (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders). * Receipt of CBT-I, BBTi, or other behavioral sleep interventions within the past 3 months. * Pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

insomnia obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Comorbid insomnia and sleep apnea Insomnia Obstructive sleep apnea

How to take part

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

  1. 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 ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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