Effects of sleeping position on COPD patients
Sleep Position and Sleep Quality in Chronic Obstructive Pulmonary Disease- a Prospective, Open Label, Randomized, Cross-over Clinical Trial
NA · Vastra Gotaland Region · NCT04963205
This study tests whether changing sleeping positions with an adjustable bed can help people with severe COPD sleep better and feel more comfortable at night.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region (other gov) |
| Locations | 1 site (Gothenburg, VGR) |
| Trial ID | NCT04963205 on ClinicalTrials.gov |
What this trial studies
This study investigates how different sleeping positions, facilitated by an adjustable bed backrest, affect sleep quality in patients with chronic obstructive pulmonary disease (COPD). It focuses on patients with severe COPD who often experience sleep disturbances, including breathing difficulties during the night. Participants will be monitored to assess the impact of these interventions on their sleep-related symptoms and overall well-being. The study aims to provide insights into optimizing sleep conditions for better management of COPD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of COPD and significant sleep difficulties.
Not a fit: Patients with clinically significant sleep disorders treated with CPAP or other severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sleep quality and overall health outcomes for patients with COPD.
How similar studies have performed: While studies on sleep disorders in COPD patients exist, the specific focus on adjustable sleeping positions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gothenburg, VGR
- COPD-center, Sahlgrenska University Hospital — Gothenburg, VGR, Sweden (RECRUITING)
Study contacts
- Study coordinator: Lowie Vanfleteren
- Email: lowie.vanfleteren@vgregion.se
- Phone: +46736601730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COPD, Sleep, Sleep positions, Adjustable bed backrest