Clinical trial NCT04963205: Sleeping Position Study in COPD Patients
Official title: Sleep Position and Sleep Quality in Chronic Obstructive Pulmonary Disease- a Prospective, Open Label, Randomized, Cross-over Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Sleep
Keywords: COPD
Sleep
Sleep positions
Adjustable bed backrest
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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:

1. To evaluate if adjusted sleeping position improves total sleep time, respiratory patterns, oxygen saturation and heart rate (measured by CASIS, WatchPat and Sleepiz).
2. To investigate if adjusted sleeping position decreases COPD-related symptoms during sleep and daytime (measured with CAT score).
3. To evaluate if adjusted sleeping position reduces patient's fatigue during the day (measured with FSS questionnaire).
4. 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).
5. 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.


Eligibility criteria: Inclusion Criteria:

1. Confirmed COPD diagnosis
2. FEV1\< 50%
3. COPD grade B, D
4. Male or female patients, aged ≥40 years
5. Difficulties with sleep, as defined by result of 4-5 points in sleep-related question in CAT questionnaire
6. A bed that is possible to adjust to the electric bed backrest
7. Signed informed consent form.

Exclusion Criteria:

1. 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
2. Long-term stay (\>1 week) away from home during the study period, where there is no possibility to use the electrical bed backrest.
3. Person that cannot communicate in Swedish language.
4. 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)
5. Already enrolled in other studies perceived to interfere with this protocol
6. Clinically significant disorders not allowing to maintain a sitting position during sleep including severe back pain, lumbalgia, spinal stenosis
7. Patients inability or unwillingness to sleep in the sitting position.

Primary outcomes:
measure: Impact of COPD on sleep quality
timeFrame: Baseline, 4 weeks and 9 weeks after baseline
Secondary outcomes:
measure: Total sleep time
timeFrame: 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
measure: Respiratory disturbance index
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Number of apneas or hypopneas
timeFrame: 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
measure: Oxygen desaturation index
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Oxygen saturation
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Central apnea-hypopnea index
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Cheyne-Stokes respiration
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Pulse rate
timeFrame: 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
measure: Wake/ sleep stages
timeFrame: 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
measure: Rapid eye movement stage time
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Sleeping body position
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Breathing rate
timeFrame: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
measure: Respiratory Irregularity Index
timeFrame: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
measure: Snoring level
timeFrame: Baseline, 3 weeks after and 7 weeks after.
measure: Time in bed
timeFrame: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
measure: COPD-related symptoms
timeFrame: Baseline, 4 weeks and 9 weeks after baseline
measure: Fatigue
timeFrame: Baseline, 4 weeks and 9 weeks after baseline
measure: Occupational activity
timeFrame: Baseline, 4 weeks and 9 weeks after baseline
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: COPD-center, Sahlgrenska University Hospital
state: VGR
Study officials:
References: