AzTrials
AzTrials

Insomnia ChronicTreatSleepCHDNCT06749951

Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease

A study testing Cognitive Behavioural Therapy for insomnia (CBT-I) and Sleep Hygiene Advice in people with Insomnia Chronic and Coronary Heart Disease, run by Vestre Viken Hospital Trust at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Insomnia Chronic, Coronary Heart Disease
What is being tested?
Cognitive Behavioural Therapy for insomnia (CBT-I) and Sleep Hygiene Advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteNorway
Study dates
30 Dec 2024to 15 Jun 2026
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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:
  • 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.
  • 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
  • Not being able to understand Norwegian.
  • No other significant sleep disorder, as assessed via the Structured Clinical Interview for Sleep disorders (Kallestad et al., 2022)
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

John D Munkhaugen, MD, PhD contact

+4797524194

johmun@vestreviken.no

Toril Dammen, MD, PhD contact

+4790163433

toril.dammen@medisin.uio.no

Norway1 site, 1 recruiting

  • Vestre Viken Trust Drammen hospital

    Drammen, Buskerud, 3014

    Anja Lia, +4792460856, anjlia@vestreviken.no

    Recruiting

Other trials in Norway

About this study

Official title: Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease: A Randomized Controlled Trial With Six Months Follow-up

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.

Being tested
Cognitive Behavioural Therapy for insomnia (CBT-I), Sleep Hygiene Advice
Medical subject headings
Sleep Initiation and Maintenance Disorders, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioural Therapy for insomnia (CBT-I)Other

    Five 60-90 minutes weekly sessions delivered by an appropriately trained cardiac nurse at a cardiology department. The CBT-I intervention will follow a manualized treatment protocol developed by Espie and colleagues (Espie et al. 2001, 2007, 2008) and evaluated in a number of published RCTs using CBT-I. The key components of this intervention include sleep hygiene advice, stimulus control, sleep restriction, relaxation training, and cognitive restructuring.

  • Sleep Hygiene AdviceOther

    "Sleep well" is a 16-page written brochure developed by the Directorate of Health in Norway for dissemination to patients with sleep problems including insomnia. It covers general sleep hygiene advice (setting a regular bed-time, avoiding stimulants, alcohol and exercise in the evening, sleeping in a quiet bedroom, advice of practicing relaxation technique and postpone worries).

Study groups in NCT06749951
Study groupRoleWhat they receive
Cognitive Behavioural Therapy for insomnia (CBT-I)ExperimentalNot described
Receives: Other: Cognitive Behavioural Therapy for insomnia (CBT-I)
Sleep Hygiene AdviceActive comparatorNot described
Receives: Other: Sleep Hygiene Advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission clinical diagnosis of insomnia

    Between- and within- group differences in the proportion witn remission of insomnia diagnosis assessed by the Bergen Insomnia Scale

    Measured: From baseline to weeks 6-8 and 26

  2. Changes in insomnia severity

    Between- and within- group differences in insomnia severity assessed by the Insomnia Severity Index

    Measured: From baseline to weeks 6-8 and 26

Secondary outcomes (14)

  1. Changes in insomnia assessed by the Pittsburgh Sleep Quality Index

    Between- and within- group differences in insomnia assessed by the Pittsburgh Sleep Quality Index with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  2. Changes in subjective sleep efficiency

    Between- and within- group differences in sleep efficiency assessed by a self-report sleep diary with higher scores indicating better outcomes

    Measured: From baseline to weeks 6-8 and 26

  3. Changes in objective sleep efficiency

    Between- and within- group differences in sleep efficiency assessed by an assessed by an actigraph with higher scores indicating better outcomes

    Measured: From baseline to weeks 6-8 and 26

  4. Changes in subjective total sleep time

    Between- and within- group differences in total sleep time assessed by a self-report sleep diary with higher scores indicating better outcomes

    Measured: From baseline to weeks 6-8 and 26

  5. Changes in objective total sleep time

    Between- and within- group differences in total sleep time assessed by an assessed by an actigraph with higher scores indicating better outcomes

    Measured: From baseline to weeks 6-8 and 26

  6. Changes in subjective sleep onset latency

    Between- and within- group differences in sleep onset latency assessed by a self-report sleep diary with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  7. Changes in objective sleep onset latency

    Between- and within- group differences in sleep onset latency assessed by an assessed by an actigraph with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  8. Changes in subjective wake after sleep onset

    Between- and within- group differences in wake after sleep onset assessed by a self-report sleep diary with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  9. Changes in objective wake after sleep onset

    Between- and within- group differences in wake after sleep onset assessed by an assessed by an actigraph with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  10. Changes in symptoms of depression and anxiety

    Between- and within- group differences in symptoms of depression and anxiety assessed by the Hospital and Anxiety Depression Scale with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  11. Changes in daytime sleepiness

    Between- and within- group differences in daytime sleepiness assessed by the Epworth Sleepiness Scale with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  12. Changes in fatigue

    Between- and within- group differences in fatigue assessed by the Chalder Fatigue Scale with higher scores indicating worse outcomes

    Measured: From baseline to weeks 6-8 and 26

  13. Changes in general quality of life

    Between- and within- group differences in quality of life assessed by the 5-level EQ-5D version with higher scores indicating better outcomes

    Measured: From baseline to weeks 6-8 and 26

  14. Changes in sleep-related quality of life

    Between- and within- group differences in sleep-related quality of life assessed by the Glasgow Sleep Impact Scale with higher scores indicating better outcomes

    Measured: From baseline to weeks 6-8 and 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start30 Dec 2024
  3. Primary completion15 Jun 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

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
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06749951
Sponsor's protocol ID
678911
Acronym
TreatSleepCHD
Status last verified
Jan 2025
First submitted
11 Dec 2024
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioural Therapy for insomnia (CBT-I) and Sleep Hygiene Advice in people with Insomnia Chronic and Coronary Heart Disease, run by Vestre Viken Hospital Trust at 1 site in Norway.

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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

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 John D Munkhaugen, MD, PhD (+4797524194, johmun@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission clinical diagnosis of insomnia (time frame: From baseline to weeks 6-8 and 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06749951.

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 9 Jan 2025.

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