Effective of Early Treatment of Insomnia on the Adherence of CPAP

Starting soon · Not applicable

Conditions studied: Obstructive Sleep Apnea (OSA), Insomnia Chronic

In brief

This study includes patients suffering from both sleep apnea and insomnia. All participants receive treatment with CPAP. Half of the participants additionally receive a digital program to treat insomnia, initiated at the same time as CPAP. The other half follows usual care and will be able to access the program after 6 months. The aim is to determine whether treating insomnia earlier improves CPAP use and overall health.

Key facts

Study ID: NCT07556432
Run by: Centre Hospitalier Universitaire Vaudois
People needed: 120
Starts: 2026-06-01
Expected to finish: 2028-12-31
Last updated by the study team: 2026-04-29

Who can join

Age: 45 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

45-65 years of age
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
Diagnosis of chronic insomnia according to the International Classification of Sleep Disorders (ICSD 3-TR).31
Ability to communicate in French
Ability to provide informed consent
Accept to receive information about incidental findings
Ownership of a smartphone running at least Android 9 (API version 28+) or iOS 12.2+.

You may not qualify if…

Current treatment for OSAS
Current or past treatment for chronic insomnia (CBT-I)
Severe restless legs syndrome
REM sleep behaviour disorder
Neurological diseases (stroke, Parkinson's disease, etc.)
Severe hypertension (≥180 mmHg systolic or requiring ≥3 antihypertensive medications)
Respiratory failure (oxygen saturation during wakefulness <90%)
Severe heart failure (NYHA class III-IV)
High-risk alcohol consumption (≥14 units/week)
Known pregnancy
Epilepsy or history of epileptic seizures (ICD-11: 8A6; ICD-10: G40)
Known bipolar disorder of any type (ICD-11: 6A60, 6A61, 6A6Y, 6A6Z; ICD-10: F31)
Known Acute and transient psychotic disorder (ICD-11: 6A23; ICD-10: F23)
Known Active suicidal ideation
Known or suspected severe parasomnias incompatible with programme use (e.g., sleepwalking:
Known Severe cardiovascular disease that may contraindicate unsupervised CBT-I strategies (e.g., unstable arrhythmias, angina pectoris)
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

Full record on ClinicalTrials.gov

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