Sleeping Position Study in COPD Patients

COPD Clinical Trial

Official title: Sleep Position and Sleep Quality in Chronic Obstructive Pulmonary Disease- a Prospective, Open Label, Randomized, Cross-over Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• COPD
• Sleep

• NCT number: NCT04963205
• Study type: Interventional
• Source: Vastra Gotaland Region
• Contact: Lowie Vanfleteren
• Phone: +46736601730
• Email: lowie.vanfleteren@vgregion.se
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2022
• Completion date: May 30, 2026