Sleeping Position Study in COPD Patients

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.

Conditions

• COPD
• Sleep

Interventions

DEVICE

Adjustable bed backrest

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.

OTHER

Standard bed

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.

Sponsors & Collaborators

• Lowie Vanfleteren

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-17

Primary Completion

2025-12-23

Completion

2026-04-30

Countries

• Sweden

Study Locations