Obstructive Sleep Apnea (OSA)CoPAPNCT07556432
Effective of Early Treatment of Insomnia on the Adherence of CPAP
A study testing digital CBT-I and CPAP in people with Obstructive Sleep Apnea (OSA) and Insomnia Chronic, run by Centre Hospitalier Universitaire Vaudois.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Insomnia Chronic
- What is being tested?
- digital CBT-I and CPAP
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comorbid Insomnia and Sleep Apnea (COMISA): Can Early Treatment of Insomnia Improve Adherence to CPAP Therapy?
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.
Read the detailed description
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:
- To evaluate the effect of concurrent CBT-I on cardiovascular health
- To evaluate the effect of concurrent CBT-I on cognitive performance
Exploratory objectives of the study are:
- To evaluate the effect of concurrent CBT-I on sleep quality and insomnia symptoms in COMISA patients under CPAP treatment.
- To evaluate the effect of concurrent CBT-I on depression and anxiety symptoms in COMISA patients under CPAP treatment.
- To evaluate the effect of concurrent CBT-I on the residual sleepiness and fatigue under CPAP treatment.
- To evaluate the effect of concurrent CBT-I on quality of life in COMISA patients under CPAP treatment.
- To explore whether improvement in insomnia symptoms following CBT-I is associated with CPAP compliance within the CBT-I + CPAP group (comparison between participants with and without improvement in insomnia symptoms).
2.3 Primary and secondary endpoints Primary endpoint
The primary endpoint will be derived from objective data recorded by the CPAP device:
- CPAP compliance, defined as the average nightly use (in minutes) over the last 3 months, measured in the middle and end of the study.
Secondary endpoints
The following secondary outcomes will be assessed:
Sleep-related and subjective measures:
- Cognitive Failures Questionnaire 2.0 (CFQ 2.0): assessment of subjective cognitive complaints.17
- Epworth Sleepiness Scale (ESS): assessment of daytime sleepiness.18
- Pittsburgh Sleep Quality Index (PSQI): evaluation of sleep quality over a 1-month period.19
- Quebec Sleep Questionnaire (QSQ).20
- Insomnia Severity Index (ISI): assessment of insomnia severity.21
- Fatigue Severity Scale (FSS): assessment of fatigue levels.22
- Hospital Anxiety and Depression Scale (HADS): assessment of anxiety and depressive symptoms.23
Objective neurocognitive performance:
- Montreal Cognitive Assessment (MoCA): global cognitive functioning.24
- Trail Making Test (Parts A and B): attention, processing speed, and executive function.25
- Stroop Test (Victoria version): cognitive flexibility and inhibitory control.26
- Verbal Fluency Tests (phonemic and semantic/animal): verbal executive function and lexical access.27
- Free and Cued Selective Reminding Test (FCSRT): visuospatial attention and processing speed.28
Cardiovascular measures:
- 24 hours Ambulatory Blood Pressure Monitoring (ABPM) and heart rate will be recorded at baseline and at 6 months.
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:
- Epworth Sleepiness Scale (ESS)
- Quebec Sleep Questionnaire (QSQ)
- Insomnia Severity Index (ISI)
- Hospital Anxiety and Depression Scale (HADS)
- Pittsburgh Sleep Quality Index (PSQI)
A comprehensive neurocognitive assessment will then be performed, including:
- Montreal Cognitive Assessment (MoCA)
- Trail Making Test
- Stroop Test (Victoria version)
- Verbal Fluency Tests (phonemic and semantic)
- Five-Point Star Cancellation Test (FCSRT)
- Cognitive Failures Questionnaire 2.0 (CFQ 2.0) to assess subjective cognitive complaints
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:
- sleep hygiene and sleep-wake scheduling
- sleep restriction therapy
- stimulus control techniques
- behavioural activation
- relaxation exercises
- strategies to address dysfunctional thoughts, cognitive rumination, and conditioned arousal
- relapse-prevention tools
- In addition to the core modules, participants have access to:
- an integrated sleep diary (agenda du sommeil)
- regular symptom check-ins
- planning tools for energising and healthy activities
- individualized goal-setting and progress monitoring
- Participants are encouraged to implement exercises in daily life between modules.
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.
- Conditions
- Obstructive Sleep Apnea (OSA), Insomnia Chronic
- Being tested
- digital CBT-I, CPAP
- Keywords
- Obstructive sleep apnea, OSA, CPAP, COMISA, cognitve behavorial therapy for insomnia, cognitive health, cardiovascular health
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital CBT-IBehavioural
The investigators add digital CBT-I intervention for the CPAP + CBT-I group
CPAPDevice
CPAP as usual
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | CPAP + usual care Receives: Device: CPAP |
| CPAP + CBT-I | Experimental | CPAP + cognitive behavorial therapy for insomnia Receives: Behavioral: digital CBT-I; Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP adherence
mean hours of CPAP use over the prior three months
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Solelhac Geoffroy, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556432
- Sponsor's protocol ID
- CIRS-COPAP
- Acronym
- CoPAP
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbid Insomnia and Sleep Apnea (COMISA): Can Early Treatment of Insomnia Improve Adherence to CPAP Therapy?
- ClinicalTrials.gov ID
- NCT07556432
- Acronym / sponsor ID
- CoPAP / CIRS-COPAP
- Conditions
- Obstructive Sleep Apnea (OSA), Insomnia Chronic
- Keywords
- Obstructive sleep apnea, OSA, CPAP, COMISA, cognitve behavorial therapy for insomnia, cognitive health, cardiovascular health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To evaluate the effect of concurrent CBT-I on cardiovascular health
- To evaluate the effect of concurrent CBT-I on cognitive performance
Exploratory objectives of the study are:
- To evaluate the effect of concurrent CBT-I on sleep quality and insomnia symptoms in COMISA patients under CPAP treatment.
- To evaluate the effect of concurrent CBT-I on depression and anxiety symptoms in COMISA patients under CPAP treatment.
- To evaluate the effect of concurrent CBT-I on the residual sleepiness and fatigue under CPAP treatment.
- To evaluate the effect of concurrent CBT-I on quality of life in COMISA patients under CPAP treatment.
- To explore whether improvement in insomnia symptoms following CBT-I is associated with CPAP compliance within the CBT-I + CPAP group (comparison between participants with and without improvement in insomnia symptoms).
2.3 Primary and secondary endpoints Primary endpoint
The primary endpoint will be derived from objective data recorded by the CPAP device:
- CPAP compliance, defined as the average nightly use (in minutes) over the last 3 months, measured in the middle and end of the study.
Secondary endpoints
The following secondary outcomes will be assessed:
Sleep-related and subjective measures:
- Cognitive Failures Questionnaire 2.0 (CFQ 2.0): assessment of subjective cognitive complaints.17
- Epworth Sleepiness Scale (ESS): assessment of daytime sleepiness.18
- Pittsburgh Sleep Quality Index (PSQI): evaluation of sleep quality over a 1-month period.19
- Quebec Sleep Questionnaire (QSQ).20
- Insomnia Severity Index (ISI): assessment of insomnia severity.21
- Fatigue Severity Scale (FSS): assessment of fatigue levels.22
- Hospital Anxiety and Depression Scale (HADS): assessment of anxiety and depressive symptoms.23
Objective neurocognitive performance:
- Montreal Cognitive Assessment (MoCA): global cognitive functioning.24
- Trail Making Test (Parts A and B): attention, processing speed, and executive function.25
- Stroop Test (Victoria version): cognitive flexibility and inhibitory control.26
- Verbal Fluency Tests (phonemic and semantic/animal): verbal executive function and lexical access.27
- Free and Cued Selective Reminding Test (FCSRT): visuospatial attention and processing speed.28
Cardiovascular measures:
- 24 hours Ambulatory Blood Pressure Monitoring (ABPM) and heart rate will be recorded at baseline and at 6 months.
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:
- Epworth Sleepiness Scale (ESS)
- Quebec Sleep Questionnaire (QSQ)
- Insomnia Severity Index (ISI)
- Hospital Anxiety and Depression Scale (HADS)
- Pittsburgh Sleep Quality Index (PSQI)
A comprehensive neurocognitive assessment will then be performed, including:
- Montreal Cognitive Assessment (MoCA)
- Trail Making Test
- Stroop Test (Victoria version)
- Verbal Fluency Tests (phonemic and semantic)
- Five-Point Star Cancellation Test (FCSRT)
- Cognitive Failures Questionnaire 2.0 (CFQ 2.0) to assess subjective cognitive complaints
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:
- sleep hygiene and sleep-wake scheduling
- sleep restriction therapy
- stimulus control techniques
- behavioural activation
- relaxation exercises
- strategies to address dysfunctional thoughts, cognitive rumination, and conditioned arousal
- relapse-prevention tools
- In addition to the core modules, participants have access to:
- an integrated sleep diary (agenda du sommeil)
- regular symptom check-ins
- planning tools for energising and healthy activities
- individualized goal-setting and progress monitoring
- Participants are encouraged to implement exercises in daily life between modules.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Device: CPAPCPAP + usual care |
| CPAP + CBT-I | Experimental | Behavioral: digital CBT-I, Device: CPAPCPAP + cognitive behavorial therapy for insomnia |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital CBT-IThe investigators add digital CBT-I intervention for the CPAP + CBT-I group | Behavioural | CPAP + CBT-I |
| CPAPCPAP as usual | Device | CPAP, CPAP + CBT-I |
Primary outcome
CPAP adherence
Time frame: 6 months
mean hours of CPAP use over the prior three months
9 secondary outcomes
Change in ambulatory heart rate
Time frame: Baseline to 6 months
Change in ambulatory systolic blood pressure
Time frame: Baseline to 6 months
Change in ambulatory diastolic blood pressure
Time frame: Baseline to 6 months
Change in cognitive performance assessed by the Montreal Cognitive Assessment
Time frame: Baseline to 6 months
Change in processing speed assessed by the Trail Making Test
Time frame: Baseline to 6 months
Change in executive function assessed by the Stroop Color-Word Test
Time frame: Baseline to 6 months
Change in verbal fluency
Time frame: Baseline to 6 months
Change in episodic memory assessed by the Free and Cued Selective Reminding Test
Time frame: Baseline to 6 months
Change in subjective cognitive complaints assessed by the Cognitive Failures Questionnaire
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing digital CBT-I and CPAP in people with Obstructive Sleep Apnea (OSA) and Insomnia Chronic, run by Centre Hospitalier Universitaire Vaudois.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoffroy OB Solelhac (+41213146748, geoffroy.solelhac@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.