None listed
Conditions
Brief summary
Emerging evidence suggests that sleep quality at night may influence how short of breath people with COPD (chronic obstructive pulmonary disease) feel during the daytime. The effects of reduced sleep on breathlessness in COPD have not been assessed. Therefore, this study aims to investigate the effects of reduced sleep duration on breathlessness and exercise capacity, as measured by cycle ergometer cardiopulmonary exercise testing, in people with COPD. Outcomes will be assessed via a randomized, controlled, crossover clinical trial design.
Interventions
Sleep restriction (4 hour total sleep time) on one night, from midnight to 4am (one single continuous window).
This intervention occurs on a single night.
Participants will be asked to abstain from drinking coffee and/or napping from 4am until the exercise test, which will occur between 8-9am on the same day. A taxi will transport them to/from the hospital where the exercise test is conducted.
A sleep tracker (Withings Sleep Analyzer) will be in place under each participant's mattress to mon
Sleep restriction (4 hour total sleep time) on one night, from midnight to 4am (one single continuous window). This intervention occurs on a single night. Participants will be asked to abstain from drinking coffee and/or napping from 4am until the exercise test, which will occur between 8-9am on the same day. A taxi will transport them to/from the hospital where the exercise test is conducted. A sleep tracker (Withings Sleep Analyzer) will be in place under each participant's mattress to monitor sleep duration and timing. As a crossover trial, there will be a minimum 7 day period between sleep intervention nights (one night is restricted to four hours, the other is unrestricted). The cardiopulmonary exercise test is performed on a cycle ergometer.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- COPD, defined as a post-bronchodilator FEV1/FVC ratio of <0.70 or less than the lower limit of normal - Self-reported nightly sleep duration of at least 6 hours - Chronic breathlessness (as defined by a modified Medical Research Council (mMRC) Dyspnea Scale score of 3 or more despite optimal inhaled therapy
Exclusion criteria
- Moderate to severe COPD exacerbation in the past 6 weeks - Change in COPD medication in the past 7 days (except as needed medications) - Asthma - Regular use of sedatives or hypnotics for sleep - Pregnant or planning pregnancy during the study - Breathlessness due to any other systemic condition - Contraindication to CPET (uncontrolled ischemic heart disease; syncope; uncontrolled arrhythmia; acute myocarditis/pericarditis; acute pulmonary edema; severe cardiac valve stenosis; inability to follow instructions; exercise-induced oxyhemoglobin desaturation to <80% on room air) - Supplemental oxygen use - Attention-critical occupation (e.g. commercial driver etc.) - Inability to adhere to the sleep restriction protocol - Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound data interpretation
Outcome results
None listed