Sleep Position and Sleep Quality in Chronic Obstructive Pulmonary Disease- a Prospective, Open Label, Randomized, Cross-over Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Impact of COPD on sleep quality
研究概览
简要总结
Background: Chronic obstructive pulmonary disease (COPD) is a common chronic disease characterized by persistent respiratory symptoms and airflow restriction, due to airway and/ or alveolar abnormalities usually caused by significant exposure to harmful particles or gases, in particular cigarette smoking. Sleep disorders are common in society and it is not surprising that they also affect individuals with COPD. Patients with COPD, especially those in severe stages of the disease suffer from many sleep disorders and its prevalence varies depending on the disease. Epidemiological studies report that approximately 75% of COPD patients experience nocturnal symptoms of the disease. The most common are sleep-breathing disorders (nocturnal hypoxemia, central sleep apnea, difficulty breathing, sleep-related hypoventilation), insomnia and sensory motor disorders during sleep, including restless legs syndrome. Patients with COPD not only experience poorer sleep quality and concomitant sleep disorders but also have a higher chance of sudden nocturnal death, especially during a period of COPD exacerbation.
Scientific studies show that elevated posture during sleep (>30 degrees raised head and back from the supine position) has a positive effect on sleep quality. To date, this has not been proven in patients with COPD who are a special group with sleep disorders.
Research questions and objectives: The primary study objective is to evaluate if adjusted sleeping position with electrical bed backrest improves the quality of sleep in patients with COPD.
The exploratory objectives are:
- To evaluate if adjusted sleeping position improves total sleep time, respiratory patterns, oxygen saturation and heart rate (measured by CASIS, WatchPat and Sleepiz).
- To investigate if adjusted sleeping position decreases COPD-related symptoms during sleep and daytime (measured with CAT score).
- To evaluate if adjusted sleeping position reduces patient's fatigue during the day (measured with FSS questionnaire).
- To evaluate if better sleep at night is associated with more energy, more activity and less breaks for rest during the day (measured with OQ-S, 6MWT and smartwatch).
- To compare the results from the two sleep recording technologies (single night minimal contact sleep recorder-WatchPat versus several nights without contact sleep recorder-Sleepiz).
Study design: Prospective, open label, cross-over clinical trial with randomized treatment order. Every subject will use the assigned intervention for 4 weeks. The intervention is an electrical bed backrest used during sleep time. The randomization will be non-adjusted, in ratio 1:1. A total of 40 patients will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COPD diagnosis
- •COPD grade B, D
- •Male or female patients, aged ≥40 years
- •Difficulties with sleep, as defined by result of 4-5 points in sleep-related question in CAT questionnaire
- •A bed that is possible to adjust to the electric bed backrest
- •Signed informed consent form.
排除标准
- •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
- •Long-term stay (>1 week) away from home during the study period, where there is no possibility to use the electrical bed backrest.
- •Person that cannot communicate in Swedish language.
- •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)
- •Already enrolled in other studies perceived to interfere with this protocol
- •Clinically significant disorders not allowing to maintain a sitting position during sleep including severe back pain, lumbalgia, spinal stenosis
- •Patients inability or unwillingness to sleep in the sitting position.
研究组 & 干预措施
Adjustable bed backrest
Sleeping in elevated body position (>30 degrees from supine position) for 4 weeks is a requirement for the intervention group. Patients can define their own most comfortable position during the night.
干预措施: Adjustable bed backrest (Device)
Usual bed
Sleeping in a standard bed and "flat" (<30 degrees from supine position) position for 4 weeks. Patients can define their own most comfortable position during the night.
干预措施: Standard bed (Other)
结局指标
主要结局
Impact of COPD on sleep quality
时间窗: Baseline, 4 weeks and 9 weeks after baseline
Change in quality of sleep with be objectively measured by the COPD and Asthma Sleep Impact Scale (CASIS). The 7 question survey, each item scores from 1 to 5 (higher score indicates greater impact) for a maximum of 35. CASIS raw scores can be linearly transformed to a 0-100 total scale score.
次要结局
- Total sleep time(Constant monitoring during 4 weeks of intervention and 4 weeks of control arm for Sleepiz; Baseline, 3 weeks after and 7 weeks after for WatchPAT)
- Oxygen desaturation index(Baseline, 3 weeks after and 7 weeks after.)
- Respiratory disturbance index(Baseline, 3 weeks after and 7 weeks after.)
- Number of apneas or hypopneas(Constant monitoring during 4 weeks of intervention and 4 weeks of control arm for Sleepiz; Baseline, 3 weeks after and 7 weeks after for WatchPAT)
- Oxygen saturation(Baseline, 3 weeks after and 7 weeks after.)
- Central apnea-hypopnea index(Baseline, 3 weeks after and 7 weeks after.)
- Cheyne-Stokes respiration(Baseline, 3 weeks after and 7 weeks after.)
- Pulse rate(Constant monitoring during 4 weeks of intervention and 4 weeks of control arm for Sleepiz; Baseline, 3 weeks after and 7 weeks after for WatchPAT)
- Wake/ sleep stages(Constant monitoring during 4 weeks of intervention and 4 weeks of control arm for Sleepiz; Baseline, 3 weeks after and 7 weeks after for WatchPAT)
- Rapid eye movement stage time(Baseline, 3 weeks after and 7 weeks after.)
- Sleeping body position(Baseline, 3 weeks after and 7 weeks after.)
- Breathing rate(Constant monitoring during 4 weeks intervention and 4 weeks control arm.)
- Respiratory Irregularity Index(Constant monitoring during 4 weeks intervention and 4 weeks control arm.)
- Snoring level(Baseline, 3 weeks after and 7 weeks after.)
- Time in bed(Constant monitoring during 4 weeks intervention and 4 weeks control arm.)
- COPD-related symptoms(Baseline, 4 weeks and 9 weeks after baseline)
- Fatigue(Baseline, 4 weeks and 9 weeks after baseline)
- Occupational activity(Baseline, 4 weeks and 9 weeks after baseline)
研究者
Lowie Vanfleteren
Principal Investigator, Head of COPD-center
Vastra Gotaland Region