Taking people in NorwayNo phase

Sleep Therapy for Insomnia in Adults With Coronary Heart Disease

Tests group sleep therapy against sleep advice in adults with heart disease and insomnia.

Key facts

Who runs it: Vestre Viken Hospital Trust
Where: Drammen, NorwaySee the site
Trial code: NCT06749951
Registry title: Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
Status: Recruiting
People taking part: 76 people, planned
Started: 30 Dec 2024
Planned end: 15 Jun 2026
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Cognitive Behavioural Therapy for insomnia (CBT-I)
Sleep Hygiene Advice
Record updated: 9 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with coronary heart disease who also have insomnia. It tests a short group sleep therapy (CBT-I) against sleep hygiene advice.

Age: 18 to 75 years
Sex: All sexes can join.
Disease stage: Coronary heart disease: hospitalised with a heart attack, or angiography-verified coronary atherosclerosis, or a coronary revascularisation procedure at Drammen Hospital 2021-2024. A positive score for insomnia on the Bergen Insomnia Score.
Earlier treatment: People receiving other psychological treatments at the same time cannot join.
Biomarker or test result: A positive Bergen Insomnia Score. At least 10 of 14 daily sleep diaries completed before randomisation.

Main reasons for not taking part

Moderate or severe memory or thinking problems
Heart failure, or NT-proBNP above 125 pg/mL
Another significant sleep disorder, or obstructive sleep apnea not treated with CPAP
Short life expectancy (under 12 months)
Not able to understand Norwegian

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

Aged 18-75 years and signed informed consent and expected cooperation according to ICH/GCP and national/local regulations
Hospitalised with acute myocardial infarction and/or angiography-verified coronary atherosclerosis, or a coronary revascularisation procedure at Drammen Hospital 2021-2024
A positive score for insomnia measured with Bergen Insomnia Score
At least 10 of 14 daily diaries completed of the sleep diary during pre-randomization assessment

Who cannot take part

Moderate or severe cognitive impairment (i.e. recorded in hospital records or a Montreal Cognitive Assessment brief version score < 11), seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work
A clinical diagnosis of Obstructive Sleep Apnea (OSA) (not treated with CPAP) recorded in the hospital medical records, under evaluation for OSA, and/or a score ≥5 on the STOP-Bang OSA screening questionnaire
Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to:
Neurological or musculoskeletal disorders that restrict movement of the dominant arm because of the possible confounding effects on wrist actigraphy recordings
A diagnosis of heart failure recorded in the hospital medical records and/or an NT-proBNP >125 pg/mL
Short life expectancy (<12 months) due to end-organ (i.e COPD 4, CKD 4/5) or malignant diseases
No other significant sleep disorder, as assessed via the Structured Clinical Interview for Sleep disorders (Kallestad et al., 2022)
Not being able to understand Norwegian

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in Norway

Vestre Viken Trust Drammen hospitalDrammen, NorwayContact: Anja LiaTaking people

About the trial

What the trial wants to find out

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.