NCT07556432

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

April 7, 2026

Last Update Submit

April 22, 2026

Conditions

Insomnia ChronicObstructive Sleep Apnea (OSA)

Keywords

Obstructive sleep apneaOSACPAPCOMISAcognitve behavorial therapy for insomniacognitive healthcardiovascular health

Outcome Measures

Primary Outcomes (1)

  • CPAP adherence

    mean hours of CPAP use over the prior three months

    6 months

Secondary Outcomes (9)

  • Change in ambulatory heart rate

    Baseline to 6 months

  • Change in ambulatory systolic blood pressure

    Baseline to 6 months

  • Change in ambulatory diastolic blood pressure

    Baseline to 6 months

  • Change in cognitive performance assessed by the Montreal Cognitive Assessment

    Baseline to 6 months

  • Change in processing speed assessed by the Trail Making Test

    Baseline to 6 months

  • +4 more secondary outcomes

Study Arms (2)

CPAP

ACTIVE COMPARATOR

CPAP + usual care

Device: CPAP

CPAP + CBT-I

EXPERIMENTAL

CPAP + cognitive behavorial therapy for insomnia

Behavioral: digital CBT-IDevice: CPAP

Interventions

digital CBT-IBEHAVIORAL

The investigators add digital CBT-I intervention for the CPAP + CBT-I group

CPAP + CBT-I
CPAPDEVICE

CPAP as usual

CPAPCPAP + CBT-I

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Geoffroy OB Solelhac

CONTACT

+41213146748geoffroy.solelhac@chuv.ch

Isabel Maceira Ericson

CONTACT

+41213146748isabel.ericson@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 29, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04