Sleeping Position Study in COPD Patients

NCT ID: NCT04963205

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2026-05-30

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.

Conditions

COPD; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adjustable bed backrest

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Standard bed

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lowie Vanfleteren

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lowie Vanfleteren

Principal Investigator, Head of COPD-center

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

COPD-center, Sahlgrenska University Hospital

Gothenburg, VGR, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Lowie Vanfleteren

Role: CONTACT

lowie.vanfleteren@vgregion.se

+46736601730

Ann-Louise Elm Kullingsjö

Role: CONTACT

ann-louise.elm.kullingsjo@vgregion.se

+46313426394

Facility Contacts

Lowie Vanfleteren

Role: primary

lowie.vanfleteren@vgregion.se

0046736601730

Ann-Louise Elm Kullingsjö

Role: backup

ann-louise.elm.kullingsjo@vgregion.se

Other Identifiers

Sovposition studie

Identifier Type: -

Identifier Source: org_study_id