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:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT04963205
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed COPD diagnosis
2. FEV1\< 50%
3. COPD grade B, D
4. Male or female patients, aged ≥40 years
5. Difficulties with sleep, as defined by result of 4-5 points in sleep-related question in CAT questionnaire
6. A bed that is possible to adjust to the electric bed backrest
7. Signed informed consent form.
Exclusion Criteria:
1. Previous diagnosis or treatment of clinically significant sleep disorder including sleep apnea treated with continuous positive airway pressure (CPAP), insomnia, restless legs syndrome or frequent parasomnia
2. Long-term stay (\>1 week) away from home during the study period, where there is no possibility to use the electrical bed backrest.
3. Person that cannot communicate in Swedish language.
4. Unable to comply with study procedures as in the opinion of the study investigator (e.g. other severe diseases with short life expectancy or which make it impossible for the patients to participate in the study, evidence of alcohol or drug abuse, dementia, severe psychiatric disorder)
5. Already enrolled in other studies perceived to interfere with this protocol
6. Clinically significant disorders not allowing to maintain a sitting position during sleep including severe back pain, lumbalgia, spinal stenosis
7. Patients inability or unwillingness to sleep in the sitting position.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04963205
Study Brief:
Protocol Section:
NCT04963205