Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT06749951
Eligibility Criteria:
Inclusion criteria (all the following):
* 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
Exclusion criteria (any of the following):
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06749951
Study Brief:
Protocol Section:
NCT06749951