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Sleep apnea and insomnia? new study tests digital therapy to boost CPAP use

NCT ID NCT07556432

Symptom relief Sponsor: Centre Hospitalier Universitaire Vaudois 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at people who have both sleep apnea and chronic insomnia. All 120 participants will receive standard CPAP therapy for sleep apnea. Half will also get a digital program to treat their insomnia starting at the same time as CPAP. The other half will follow usual care and can access the program after 6 months. The goal is to see if early insomnia treatment helps people use CPAP more regularly and improves their health.

What this could mean

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

Active substance
digital cognitive behavioral therapy for insomnia (CBT-I)
What this could lead to
If it works, this could show that treating insomnia early improves CPAP use and overall health in people with both conditions.
What could go wrong
This is a small, early-stage trial with only 120 participants, so results may not apply to everyone. The digital program may not work as well as in-person therapy.

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 120 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

45 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: 1. 45-65 years of age 2. Diagnosis of OSAS by respiratory polygraphy or polysomnography with an apnea-hypopnea index (AHI) ≥20 when scored by PSG or ≥15 when scored by PG30 with a prescription for CPAP therapy 3. Diagnosis of chronic insomnia according to the International Classification of Sleep Disorders (ICSD 3-TR).31 4. Ability to communicate in French 5. Ability to provide informed consent 6. Accept to receive information about incidental findings 7. Ownership of a smartphone running at least Android 9 (API version 28+) or iOS 12.2+. Exclusion criteria: 1. Current treatment for OSAS 2. Current or past treatment for chronic insomnia (CBT-I) 3. Severe restless legs syndrome 4. REM sleep behaviour disorder 5. Neurological diseases (stroke, Parkinson's disease, etc.) 6. Severe hypertension (≥180 mmHg systolic or requiring ≥3 antihypertensive medications) 7. Respiratory failure (oxygen saturation during wakefulness \<90%) 8. Severe heart failure (NYHA class III-IV) 9. High-risk alcohol consumption (≥14 units/week) 10. Known pregnancy 11. Epilepsy or history of epileptic seizures (ICD-11: 8A6; ICD-10: G40) 12. Known bipolar disorder of any type (ICD-11: 6A60, 6A61, 6A6Y, 6A6Z; ICD-10: F31) 13. Known Acute and transient psychotic disorder (ICD-11: 6A23; ICD-10: F23) 14. Known Active suicidal ideation 15. Known or suspected severe parasomnias incompatible with programme use (e.g., sleepwalking: 16. Known Severe cardiovascular disease that may contraindicate unsupervised CBT-I strategies (e.g., unstable arrhythmias, angina pectoris) 17. Any medical or psychiatric condition that, in the investigator's judgment, would contraindicate the use of the CE-marked HelloBetter Insomnie digital device or participation in CBT-I

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Conditions

The condition(s) this trial relates to.

insomnia obstructive sleep apnea syndrome

As listed by the trial registrant

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

Insomnia chronic Obstructive sleep apnea (OSA)

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.