COPDNCT04963205
Sleeping Position Study in COPD Patients
A study testing Adjustable bed backrest and Standard bed in people with COPD and Sleep, run by Lowie Vanfleteren at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- Adjustable bed backrest and Standard bed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jan 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
COPD-center, Sahlgrenska University Hospital
Gothenburg, VGR, 41345
About this study
Official title: Sleep Position and Sleep Quality in Chronic Obstructive Pulmonary Disease- a Prospective, Open Label, Randomized, Cross-over Clinical Trial
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.
Read more
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:
- To evaluate if adjusted sleeping position improves total sleep time, respiratory patterns, oxygen saturation and heart rate (measured by CASIS, WatchPat and Sleepiz).
- To investigate if adjusted sleeping position decreases COPD-related symptoms during sleep and daytime (measured with CAT score).
- To evaluate if adjusted sleeping position reduces patient's fatigue during the day (measured with FSS questionnaire).
- 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).
- 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.
- Being tested
- Adjustable bed backrest, Standard bed
- Keywords
- COPD, Sleep, Sleep positions, Adjustable bed backrest
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable bed backrestDevice
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.
Standard bedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks and 9 weeks after baseline
Secondary outcomes (18)
Total sleep time
Change in total sleep time will be collected by a WatchPAT device (wrist-mounted device that records PAT signals) and Sleepiz device (contactless device).
Measured: 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
Change in respiratory indices, the respiratory disturbance index (pRDI) will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Number of apneas or hypopneas
Change in respiratory indices, the number of apneas or hypopneas recorded during the study per hour of sleep (pAHI) will be measured by WatchPAT and Sleepiz device.
Measured: 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
Change in the oxygen desaturation index (ODI) will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Oxygen saturation
Change in mean oxygen saturation (%) will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Central apnea-hypopnea index
Change in respiratory indices, the central apnea-hypopnea index (pAHIc) will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Cheyne-Stokes respiration
Change in respiratory indices, the Cheyne-Stokes respiration (%CSR) will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Pulse rate
Change in pulse rate during sleep will be measured by WatchPAT and Sleepiz device
Measured: 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
Wake/ sleep stages
Changes in wake/ sleep stages will be measured by WatchPAT and Sleepiz device.
Measured: 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
Rapid eye movement stage time
Change in rapid eye movement (REM) phase (%) will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Sleeping body position
Change in body position during sleep (supine, non-supine, prone, right, left) will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Breathing rate
Changes in breathing rate (times/minute) will be measured by Sleepiz device.
Measured: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
Respiratory Irregularity Index
Changes in respiratory regularity index will be measured by Sleepiz device.
Measured: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
Snoring level
Changes in snoring level (dB) during sleep will be measured by WatchPAT device.
Measured: Baseline, 3 weeks after and 7 weeks after.
Time in bed
Changes in total time spend in bed (measured in hours and minutes) will be measured by Sleepiz device.
Measured: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
COPD-related symptoms
Change in disease-specific related symptoms will be measured by using a COPD Assessment Test (CAT) questionnaire. CAT measures COPD symptoms with scores from 0 to 5 points (0 indicating no impact or symptoms, 5- worst possible impact or symptoms) summing up to a total CAT score range of 0-40 points.
Measured: Baseline, 4 weeks and 9 weeks after baseline
Fatigue
Changes in fatigue will be objectively measured by using the Fatigue Severity Scale (FSS). It is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers can be scored from 1 to 7 and higher score means greater fatigue severity.
Measured: Baseline, 4 weeks and 9 weeks after baseline
Occupational activity
Changes in occupational questionaire will be objectively measured by using the Occupational Questionnaire, Swedish version (OQ-S). Users classify the activity as work, play or leisure and record their perception of competence, value, and enjoyment for each activity and mark its competence and importance. The OQ-S register time use based on a pre-defined 19-hour window, from 05:00 to 00:00. Using 5-point likert-type scale indicating how well they do the activity, how important is the activity and how enjoyable it is. The higher the score, the better the individual's satisfaction, value and enjoyment of the activity.
Measured: Baseline, 4 weeks and 9 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start17 Jan 2022
- Primary completion23 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lowie Vanfleteren
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Lowie Vanfleteren, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963205
- Sponsor's protocol ID
- Sovposition studie
- Status last verified
- May 2026
- First submitted
- 8 Jun 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Position and Sleep Quality in Chronic Obstructive Pulmonary Disease- a Prospective, Open Label, Randomized, Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT04963205
- Acronym / sponsor ID
- Sovposition studie
- Keywords
- COPD, Sleep, Sleep positions, Adjustable bed backrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lowie VanfleterenOther government
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate if adjusted sleeping position improves total sleep time, respiratory patterns, oxygen saturation and heart rate (measured by CASIS, WatchPat and Sleepiz).
- To investigate if adjusted sleeping position decreases COPD-related symptoms during sleep and daytime (measured with CAT score).
- To evaluate if adjusted sleeping position reduces patient's fatigue during the day (measured with FSS questionnaire).
- 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).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjustable bed backrest | Experimental | Device: Adjustable bed backrestSleeping 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. |
| Usual bed | Active comparator | Other: Standard bedSleeping 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjustable bed backrestThe 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. | Device | Adjustable bed backrest |
| Standard bedSleeping 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. | Other | Usual bed |
Primary outcome
Impact of COPD on sleep quality
Time frame: Baseline, 4 weeks and 9 weeks after baseline
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.
18 secondary outcomes
Total sleep time
Time frame: 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
Time frame: Baseline, 3 weeks after and 7 weeks after.
Number of apneas or hypopneas
Time frame: 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
Time frame: Baseline, 3 weeks after and 7 weeks after.
Oxygen saturation
Time frame: Baseline, 3 weeks after and 7 weeks after.
Central apnea-hypopnea index
Time frame: Baseline, 3 weeks after and 7 weeks after.
Cheyne-Stokes respiration
Time frame: Baseline, 3 weeks after and 7 weeks after.
Pulse rate
Time frame: 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
Wake/ sleep stages
Time frame: 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
Rapid eye movement stage time
Time frame: Baseline, 3 weeks after and 7 weeks after.
Sleeping body position
Time frame: Baseline, 3 weeks after and 7 weeks after.
Breathing rate
Time frame: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
Respiratory Irregularity Index
Time frame: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
Snoring level
Time frame: Baseline, 3 weeks after and 7 weeks after.
Time in bed
Time frame: Constant monitoring during 4 weeks intervention and 4 weeks control arm.
COPD-related symptoms
Time frame: Baseline, 4 weeks and 9 weeks after baseline
Fatigue
Time frame: Baseline, 4 weeks and 9 weeks after baseline
Occupational activity
Time frame: Baseline, 4 weeks and 9 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable bed backrest and Standard bed in people with COPD and Sleep, run by Lowie Vanfleteren at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of COPD on sleep quality (time frame: Baseline, 4 weeks and 9 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.