An interventional study of digital CBT-I and CPAP in Obstructive Sleep Apnea (OSA) and Insomnia Chronic, sponsored by Centre Hospitalier Universitaire Vaudois. Not yet recruiting. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment
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.
2.1 Hypothesis and primary objective Our hypothesis is that concurrent treatment of insomnia with digital cognitive behavioral therapy for insomnia (CBT-I) will improve adherence to continuous positive airway pressure (CPAP) therapy in patients with COMISA. It is well-established that patients with OSAS who do not have comorbid insomnia demonstrate better adherence to CPAP therapy. By treating insomnia symptoms earlier in the course of therapy, patients may be more likely to tolerate and accept CPAP, particularly during the critical early phase when adherence habits are being formed. This may help create a more positive experience and stronger therapeutic alliance with CPAP. Additionally, patients may benefit from beginning CBT-I while they are already using CPAP, as they can tailor therapeutic strategies to their personal experience with the device, for example, by addressing specific cognitive or behavioral challenges related to mask discomfort, sleep onset latency, or nighttime awakenings.
The primary objective of this study is to assess whether initiating CBT-I at the time of CPAP prescription leads to improved treatment adherence among patients with COMISA, who are often at higher risk of non-compliance due to their insomnia symptoms.
2.2 Secondary objectives
Secondary objectives of the study are:
Exploratory objectives of the study are:
2.3 Primary and secondary endpoints Primary endpoint
The primary endpoint will be derived from objective data recorded by the CPAP device:
Secondary endpoints
The following secondary outcomes will be assessed:
Sleep-related and subjective measures:
Objective neurocognitive performance:
Cardiovascular measures:
2.4 Study design This study will be conducted in the form of a parallel-group controlled trial, with the aim of testing the potential of early CBT-I treatment to improve CPAP adherence in COMISA patients. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland.
In routine clinical practice at CHUV, CPAP is habitually prescribed for patients with obstructive sleep apnea. CBT-I may also be prescribed when chronic insomnia is identified; however, it is usually delivered face-to-face or in group format, with waiting times that can reach up to six months at the Centre Interdisciplinaire du Sommeil (CIRS). The key difference in the present trial compared to usual care is the immediate and simultaneous initiation of a digital CBT-I program at the time of CPAP prescription, without delay for de "Early CBT-I + CPAP group".
COMISA patients will be randomized 1:1 (60 patients in either group) to the CPAP alone (control group), or concurrent CPAP with digital CBT-I based on a random list created through an online randomisation tool: A computer-generated pseudorandom number generator will be used to produce the randomisation list.
The study consists in 3 visits for each group.
Baseline visit:
After verification of eligibility criteria, participants will provide written informed consent. Demographic data and ambulatory blood pressure monitoring (ABPM) and heart rate will be collected. Clinical data will be retrieved from earlier diagnostic visits before the study (from polygraphy or polysomnography). The following validated questionnaires will be administered:
A comprehensive neurocognitive assessment will then be performed, including:
After all tests have been performed, team member will inform the patient as to which group they will be in and in case they will partake in dCBT-I, answer any questions they may have regarding use and installation of the application.
3-month visit: Continuous positive airway pressure (CPAP) adherence data will be collected from the CPAP device, measured as the average nightly usage over the previous 3 months. The percentage of nights with usage greater than 4 hours and the average residual AHI will also be collected from the CPAP device. All questionnaires listed above will be re-administered, except for the neurocognitive tests.
6-month visit: CPAP adherence data will again be collected from the CPAP device (average nightly usage). The percentage of nights with usage greater than 4 hours and the average residual AHI will also be collected from the CPAP device. All questionnaires will be re-administered, and all neurocognitive tests will be repeated. ABPM and heart rate will also be recorded.
2.5 Study intervention
Early digital CBT-I group (HelloBetter Insomnie + CPAP)
Participants randomized to the early intervention group will begin digital cognitive behavioral therapy for insomnia (dCBT-I) immediately after completion of all baseline assessments. The intervention will be delivered through HelloBetter Insomnie, a CE-marked (Class I, EU MDR 2017/745) digital medical device developed by GET.ON Institut für Online Gesundheitstrainings GmbH.12
HelloBetter Insomnie consists of eight structured online modules, typically completed over 10 to 12 weeks, each requiring approximately 45-60 minutes. The modules include evidence-based CBT-I content such as:
A distinctive component of the HelloBetter programme is the availability of personalised professional support: After each completed module, participants receive written feedback within 24 hours on working days from a designated clinical psychologist trained in digital CBT-I. Each participant is followed by the same psychologist throughout the programme.
Participants will begin CPAP treatment at the same time as the digital CBT-I. CPAP therapy will follow standard clinical procedures, as prescribed by the treating sleep physician, and will not be modified by the study.
CPAP only group
Participants randomized to the late intervention group will receive usual standard-of-care CPAP therapy at baseline, identical to the early intervention group, but will not have access to digital CBT-I during the 6-month study period. This reflects the current average waiting time (\~6 months) for access to face-to-face CBT-I at the CHUV.
To ensure equity in access to care, all participants in the late group will be offered free access to HelloBetter Insomnie after completion of the 6-month study visit. CPAP treatment will be prescribed and followed according to standard clinical practice in both groups.
2.6 Patient and public involvement Patients with comorbid chronic insomnia and obstructive sleep apnea were informally consulted during routine clinical consultations with the principal investigator. These discussions focused in particular on access to cognitive behavioral therapy for insomnia (CBT-I), for which waiting times currently exceed six months at the Centre for Sleep Investigation and Research (CIRS).
Many patients expressed frustration regarding these delays and indicated that they would be willing to engage in a digital insomnia therapy. Several patients also reported that initiating CBT-I in close temporal proximity to the start of CPAP treatment could help them improve both their insomnia and their sleep apnea, provided that the delay between the two interventions was not too long. Digital CBT-I is recognised as a first-line treatment and is classified at the highest level of evidence in recent European guidelines for chronic insomnia29. This patient feedback directly informed the conception of the present study, particularly the evaluation of an early digital CBT-I intervention delivered in parallel with CPAP therapy, with the aim of reducing waiting times for this reference treatment and optimising outcomes for both conditions.
Patients will not be involved in the conduct of the trial, data analysis, or dissemination strategy. However, a lay summary of the study results will be provided to participants at the end of the trial.
Exclusion criteria:
CPAP + usual care
Device: CPAP
CPAP + cognitive behavorial therapy for insomnia
Behavioral: digital CBT-I · Device: CPAP
The investigators add digital CBT-I intervention for the CPAP + CBT-I group
CPAP as usual
CPAP adherence
mean hours of CPAP use over the prior three months
Time frame: 6 months
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 months
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 months
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 months
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 months
Change in processing speed assessed by the Trail Making Test
Measured using the Trail Making Test. Outcome is completion time in seconds. Lower values indicate better performance.
Time frame: Baseline to 6 months
Change in executive function assessed by the Stroop Color-Word Test
Measured using the Stroop Color-Word Test. Outcome is completion time or interference score (in seconds or derived score depending on version). Lower values indicate better cognitive performance (reduced interference).
Time frame: Baseline to 6 months
Change in verbal fluency
Measured using a phonemic (e.g., letter fluency) and semantic (e.g., animal naming) verbal fluency task. Outcome is the number of correct words generated in 60 seconds. Higher values indicate better performance.
Time frame: Baseline to 6 months
Change in episodic memory assessed by the Free and Cued Selective Reminding Test
Measured using the Free and Cued Selective Reminding Test (FCSRT). Outcomes include free recall and total recall scores. Scores typically range from 0 to 48, with higher scores indicating better memory performance.
Time frame: Baseline to 6 months
Change in subjective cognitive complaints assessed by the Cognitive Failures Questionnaire
Measured using the Cognitive Failures Questionnaire (CFQ-2.0). Scores range from 0 to 100, with higher scores indicating greater cognitive complaints (worse outcome).
Time frame: Baseline to 6 months
No study locations are listed for this record.
Plan to share: Undecided — The plan to share individual participant data has not yet been finalized. Data sharing may be considered upon reasonable request and in accordance with institutional and regulatory requirements.
No publications or documents are linked to this record.
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Centre Hospitalier Universitaire Vaudois