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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT04997200
Eligibility Criteria:
Inclusion Criteria: (All required)
* Age 18 years or older
* COPD diagnosed by physician in accordance with Global Initiative For Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2021), with a spirometric ratio of the forced expired volume in one second (FEV1) / forced vital capacity (FVC) \< 0.7 and a FEV1 \< 80% of predicted post bronchodilator at baseline.
* Self-reported average sleep time of six hours or longer during a normal night.
* No regular treatment with sleep medication or anxiolytics.
* Able to cycle
* Able to talk and write Swedish well enough to participate in the study procedures, as judged by the Investigator.
Exclusion Criteria:
* Resting peripheral oxygen saturation (SpO2) \< 92%
* Night shift worker
* Hospitalization or clinical instability during the last four weeks
* Treatment with supplementary oxygen at rest or during exercise
* Sleep disturbance, defined as a Pittsburgh Sleep Quality Index \>5 at baseline
* Contraindication to exercise testing in accordance with clinical practice guidelines (ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med 2003; 167:211-277)
* Expected survival shorter than six months as judged by the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04997200
Study Brief:
Protocol Section:
NCT04997200