Effect of Sleep Deprivation on Breathlessness and Exercise Capacity in COPD: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Change in breathlessness intensity (Borg CR10) between control and intervention at iso-time
研究概览
简要总结
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.
详细描述
Background:
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality in the world. Breathlessness and exercise limitation are cardinal symptoms in COPD with grave consequences for the patient. Even with optimal COPD treatment a large number of these patients experience a breathlessness which limits their everyday life. Physical activity is the main trigger of breathlessness in daily life, but knowledge is limited on how other factors may affect exercise performance, breathing and exertional breathlessness in patients with COPD.
Sleep deprivation is common in the population in patients with COPD, and especially in patients with worsening health status and during hospitalizations. As many as 40-45% of patients older than 70 experience sleep deprivation during hospitalization. As many as 21 % of patients with COPD have a disturbed sleep. A recent study on healthy young males who breathed against an inspiratory resistance showed that one night's sleep deprivation significantly reduced their respiratory endurance and induced worse and more disturbing breathlessness.
Little is known how sleep loss affects patients with COPD in an outpatient setting. Several studies have evaluated the effect of sleep deprivation on exercise capacity in young healthy adults. However, very few studies have examined the effect of sleep deprivation on the exercise capacity or exertional breathlessness in patients with COPD; most data pertain to observational studies where no intervention took place and data from a randomized controlled trial (RCT) is needed. The presence of disturbed sleep in patients with COPD - and especially in relation to worsenings and hospitalizations, could have a marked detrimental effect on their breathing, increase suffering from distressing breathlessness and potentially increase the risk of adverse health outcomes and worse prognosis. Directed actions to improve sleeping in these settings could in that case improve the patients' outcomes.
Aim:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The analyst analyzing the data will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •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.
研究组 & 干预措施
Intervention: One night's sleeplessness
A night without sleep. No daytime sleeping the day before the test. Participants are observed by staff at the trial unit during the night before the test.
干预措施: One night's sleeplessness (Behavioral)
Control: One night's normal sleep
A normal night's sleep (at least six hours) in the patient's home.
结局指标
主要结局
Change in breathlessness intensity (Borg CR10) between control and intervention at iso-time
时间窗: Measured during post-control and post-intervention exercise tests, spaced 7 days to 6 weeks apart
Change between conditions in breathlessness intensity using the Borg Category Ratio scale (Borg CR10), where 0 indicates no exertion and 10 indicates maximum exertion, at iso-time (defined as the time of the latest similar time point during both conditions (control and intervention) during a constant rate cycle cardiopulmonary exercise test (CPET).
次要结局
- Change in cardiac reserve between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in oxygen consumption between control and intervention (absolute)(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in workload (%pred) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in Minute ventilation (VE) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in oxygen consumption between control and intervention (%pred)(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in ventilatory reserve, (MVV) - (VE) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in breathlessness intensity at peak exercise (Borg CR10) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in workload (W) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in tidal volume (VT) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in dynamic hyperinflation and inspiratory capacity (IC) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in timing of the anaerobic threshold (AT) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in breathlessness unpleasantness (Borg CR10) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in time to the limit of tolerance (tLIM) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in efficacy of ventilation (VE/V'CO2-slope and ratio at the AT) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in respiratory exchange ratio (RER), defined as V'CO2/V'O2 between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in causes for stopping the test between control and intervention(Evaluated during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in breathing frequency between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in leg discomfort (Borg CR10) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in any adverse events during the control and intervention tests(Evaluated during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
- Change in V'O2 of the anaerobic threshold (AT) between control and intervention(Measured during post-control and post-intervention tests, spaced 7 days to 6 weeks apart)
研究者
Magnus Ekström
MD, PhD, Associate professor
Skane University Hospital