Sleeping Position Study in COPD Patients

NCT04963205 | Completed

• 1 other identifier: Sovposition studie
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 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. 2.To investigate if adjusted sleeping position decreases COPD-related symptoms during sleep and daytime (measured with CAT score).
3. 3.To evaluate if adjusted sleeping position reduces patient's fatigue during the day (measured with FSS questionnaire).
4. 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. 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).

Conditions

COPD; Sleep

Keywords

COPD; Sleep; Sleep positions; Adjustable bed backrest

Outcome Measures

Primary Outcomes (1)

• Impact of COPD on sleep quality

  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.

  Baseline, 4 weeks and 9 weeks after baseline

Secondary Outcomes (18)

• 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

• 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 desaturation index

  Baseline, 3 weeks after and 7 weeks after.

• Oxygen saturation

  Baseline, 3 weeks after and 7 weeks after.

Study Arms (2)

Adjustable bed backrest

EXPERIMENTAL

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.

Device: Adjustable bed backrest

Usual bed

ACTIVE COMPARATOR

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.

Other: Standard bed

Interventions

Adjustable bed backrest DEVICE

The adjustable bed backrest facilitates for the individual high lying with a fowler (90 degrees raised head and trunk) and/or semi fowler position (30-45 degrees raised head and trunk) which enables patient's lung expansion. The diaphragm is pulled downwards by the gravity allowing for lung expansion and improved ventilation. In addition, the upper airways are stretched in order to prevent upper airway narrowing during sleep (flow limitation, snoring, obstructive sleep apnea). The position relaxes the tension of the abdominal muscles, allowing for improved breathing. Patients can define their own most comfortable position during the night. Elevated body position over 30 degrees from supine position is a requirement for the intervention group. No sleeping time restrictions will be applied. One week washout period between the interventions will be used.

Adjustable bed backrest

Standard bed OTHER

Sleeping in a standard bed, in a position below 30 degrees from supine position. No sleeping time restrictions will be applied. One week washout period between the interventions will be used.

Usual bed

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed COPD diagnosis
• FEV1\< 50%
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lowie Vanfleteren: lead

Study Sites (1)

COPD-center, Sahlgrenska University Hospital

Gothenburg, VGR, 41345, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Head of COPD-center

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 15, 2021
• Study Start: January 17, 2022
• Primary Completion: December 23, 2025
• Study Completion: April 30, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

SE (1)