Effect of Sleep Deprivation on Breathlessness and Exercise Capacity in COPD (NCT04997200) | Clinical Trial Compass
CompletedNot Applicable
Effect of Sleep Deprivation on Breathlessness and Exercise Capacity in COPD
Sweden20 participantsStarted 2021-09-13
Plain-language summary
This is a randomized controlled cross-over trial designed to measure the effect of one night's sleep deprivation on exercise endurance, ventilation and breathlessness in outpatients with COPD.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change in breathlessness intensity (Borg CR10) between control and intervention at iso-time
Timeframe: Measured during post-control and post-intervention exercise tests, spaced 7 days to 6 weeks apart