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NCT06749951: TreatSleepCHD
Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
NA trial testing Cognitive Behavioural Therapy for insomnia (CBT-I) in Insomnia Chronic in 76 participants. Currently enrolling.
15 June 2026
Quick facts
| Lead sponsor | Vestre Viken Hospital Trust |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 30 December 2024 |
| Primary completion | 15 June 2026 |
| Estimated completion | 15 June 2026 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Cognitive Behavioural Therapy for insomnia (CBT-I)
- Sleep Hygiene Advice
Conditions studied
- Insomnia Chronic — all drugs for Insomnia Chronic →
- Coronary Heart Disease — all drugs for Coronary Heart Disease →
Sponsor
Vestre Viken Hospital Trust
Who can join
Adults 18 to 75, any sex, with Insomnia Chronic or Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Insomnia is prevalent (45%) in CHD patients and associated with significantly increased risk for recurrent cardiovascular events. Insomnia has recently been identified as the third most important risk factor for prognosis. However, very few insomnia patients are identified and receive treatment of insomnia today. CBT-I is the first-line treatment for insomnia, but studies on the effects in CHD patients are lacking. This project aims to document the effectiveness of Cognitive Behavioural therapy for insomnia (CBT-I) in an outpatient population with coronary heart disease (CHD). Furthermore, the biological and psychological mechanisms that may mediate the effects of the intervention will be identified. Finally, a health-economic simulation and a qualitative study of the participants experiences with CBT-I will be performed. This prospective, randomized, intervention study will continue until data have been collected for the primary outcome on 66 CHD outpatients with a diagnosis of insomnia assessed by Bergen Insomnia Scale (BIS). Participants will be randomised to a short, nurse-administered, CBT-I delivered in a group format or to sleep hygiene advice. The primary outcome will be remission from BIS-insomnia post-treatment and at 6-months follow-up. Secondary outcomes will be changes in insomnia severity, objective and subjective sleep parameters, daytime symptoms of insomnia, and quality of life. Exploratory outcomes include inflammation, cortisol, HbA1C, and cognitions/metacognitions. The project may document the effectiveness of CBT-I for a large patient-group with potentially favorable long-term effects on important clinical outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06749951
- Europe PMC full search
- ASCO Meeting Library
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Other Vestre Viken Hospital Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06749951 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vestre Viken Hospital Trust
- Last refreshed: 9 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06749951.
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