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New treatment option for Insomnia Chronic
Official title Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
ClinicalTrials.gov ID: NCT06749951
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- (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...
- 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
You likely can't join if
- (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...
- Moderate or severe cognitive impairment (i.e. recorded in hospital records or a Montreal Cognitive Assessment brief version score \< 11), seizure...
- Neurological or musculoskeletal disorders that restrict movement of the dominant arm because of the possible confounding effects on wrist actigraphy...
- 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
See the full eligibility 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
- (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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Drammen, Buskerud, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Drammen, Buskerud, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.