Effective of Early Treatment of Insomnia on the Adherence of CPAP
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorCentre Hospitalier Universitaire Vaudois
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Current treatment for OSAS
Current or past treatment for chronic insomnia (CBT-I)
Severe restless legs syndrome
REM sleep behaviour disorder
Trial design
Design model
Parallel
Treatments tested in this trial
digital CBT-I
BehavioralThe investigators add digital CBT-I intervention for the CPAP + CBT-I group
CPAP
DeviceCPAP as usual
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: CPAPActive comparator 1 intervention
Group B: CPAP + CBT-IExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
CPAP adherence
mean hours of CPAP use over the prior three months
Time frame
6 monthsSecondary outcomes
1
Change in ambulatory heart rate
Measured using 24-hour ambulatory blood pressure monitoring (millimeters of mercury, mmHg). Mean systolic blood pressure over 24 hours will be calculated. Lower values indicate better cardiovascular status.
Time frame
Baseline to 6 months2
Change in ambulatory systolic blood pressure
Measured using 24-hour ambulatory blood pressure monitoring (millimeters of mercury, mmHg). Mean systolic blood pressure over 24 hours will be calculated. Lower values indicate better cardiovascular status
Time frame
Baseline to 6 months3
Change in ambulatory diastolic blood pressure
Measured using 24-hour ambulatory blood pressure monitoring (millimeters of mercury, mmHg). Mean diastolic blood pressure over 24 hours will be calculated. Lower values indicate better cardiovascular status.
Time frame
Baseline to 6 months4
Change in cognitive performance assessed by the Montreal Cognitive Assessment
Measured using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening tool assessing multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Time frame
Baseline to 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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