COPD (Chronic Obstructive Pulmonary Disease)REARSOM/BPCONCT06677268
Respiratory Rehabilitation and Sleep Quality in COPD Patients
A study testing Rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease), run by University Hospital, Rouen at 4 sites in France.
Trial summary
COPD affects 5 to 8% of the population in France. The disease consists of inflammation of the large and small airways causing permanent obstruction of the airways and symptoms such as dyspnea, cough and sputum that worsens over time. Among all COPD patients, 40% complain of sleep disorders. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Feb 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ age 50
- COPD defined according to the GOLD 2022 criteria, clinically stable (without exacerbation for at least 4 weeks), with indication for respiratory rehabilitation
- Absence of respiratory rehabilitation in the past 12 months
- Patient affiliated to the social security system
- For women of childbearing potential who have been on effective contraception (estrogen-progestogen or intrauterine device or tubal ligation) for 1 month.
- For postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
- Patient who has read and understood the information letter and signed the consent form
Who cannot join
- BMI≥ 30 kg/m2
- Previously documented OSA (AHI \> 10/h)
- Patient with a CPAP or NIV
- Patient on systemic corticosteroid therapy
- Patient on centrally acting therapy (benzodiazepine or opiate)
- Patient with an occurrence of severe COPD exacerbation
Show all 16Show fewer
- Patient with other associated chronic respiratory insufficiency
- Patient with active cancer
- Patient with neuromuscular disease
- Patient with an osteoarticular disability or traumatic or neurological sequelae preventing participation in the respiratory rehabilitation program
- Psychiatric, cognitive or linguistic disorders with inability to understand to follow the protocol
- Patient with a contraindication to respiratory rehabilitation or any pathology preventing physical rehabilitation
- Patient with a cardiovascular contraindication to respiratory rehabilitation
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial safeguard, guardianship or curatorship
- Person subject to a legal protection measure
- Pregnant or parturient or breastfeeding woman
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Chu Amiens
Amiens, 80054
Vincent Jounieaux, Pr, Jounieaux.vincent@chu-amiens.fr
Vincent Jounieaux, Pr
- Not yet recruiting
Gh Le Havre
Le Havre, 76083
Jean Quieffin, Jean.quieffin@ch-havre.fr
Jean Quieffin, Dr
- Not yet recruiting
Centre de Sante Adir
Rouen, 76000
Adriana Portmann, Dr, adrianaportmann@yahoo.fr
Adriana Portmann, Dr
- Recruiting
Chu Rouen
Rouen, 76031
Marie-Anne Melone, Dr, marieanne.melone@chu-rouen.fr
Marie-Anne Melone, Dr
About this study
Official title: Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients With Stable COPD
COPD affects 5 to 8% of the population in France. The disease consists of inflammation of the large and small airways causing permanent obstruction of the airways and symptoms such as dyspnea, cough and sputum that worsens over time.
Among all COPD patients, 40% complain of sleep disorders. Polysomnography data showed a prolongation of sleep onset latency and a decrease in deep sleep, correlated with the severity of daytime hypoxemia. Conversely, poor sleep quality leads to an increase in dyspnea, altered quality of life and increased occurrence of COPD exacerbations.
Respiratory rehabilitation has demonstrated significant benefits on exercise capacity, dyspnea, COPD exacerbations and quality of life. To the investigators' knowledge, a few studies have investigated the relationship between physical activity and sleep quality using polysomnography in this population. Thus, the aim of the study is to evaluate the benefits of respiratory rehabilitation on sleep architecture in patients with COPD. Investigators' hypothesis is that a respiratory rehabilitation program would improve the quality of sleep measured by polysomnography. Therefore, patient with COPD and no exacerbation in the previous year will be randomly assigned to the interventional group who perform the rehabilitation program or to the control group who will not perform the program. The primary endpoint is the sleep quality estimated by total sleep time as measured by the mean of 2 independent polysomnography readings, at baseline and after the RR program in the interventional group and after 2 months of usual care in the control group.
- Being tested
- Rehabilitation
- Keywords
- polysomnography, sleep quality, physical activity, education, respiratory rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationProcedure or surgery
Patients will undergo a respiratory rehabilitation program (24 exercise sessions of 90 minutes each, three times a week for 8 weeks and up to 9 therapeutic education workshops of 1 hour)
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Rehabilitation | Experimental | Patient in this arm will perform a 2-months respiratory rehabilitation program Receives: Procedure: Rehabilitation |
| Usual care | No intervention | Patient in the control group (usual care) will have standard care without respiratory rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (TST)
measured by the average of the 2 independent polysomnography scorings
Measured: Baseline and end of respiratory rehabilitation (2 months)
Secondary outcomes (17)
Sleep onset latency
Sleep onset latency (SOL) measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
Pittsburgh sleep quality index (PSQI)
subjective sleep quality measured by the questionnaire PSQI, Minimum score: 0 (best sleep quality), Maximum score: 21 (worst sleep quality).
Measured: From enrollment to the end of the follow-up at 11 weeks
Evolution of the quality of life
measured by Saint George's Hospital Respiratory Questionnaire (SGRQ), minimum score (0): indicates no impairment (best possible health status), maximum score (100): indicates severe impairment (worst possible health status).
Measured: From enrollment to the end of the follow-up at 11 weeks
Daytime sleepiness
measured by Epworth Sleepiness Scale, minimum score of 0 (no daytime sleepiness), maximum score of 24 (severe daytime sleepiness).
Measured: From enrollment to the end of the follow-up at 11 weeks
Dyspnée
measured by the score modified Medical Research Council [mMRC], minimum score of 0 (least severe dyspnea), maximum score of 4 (most severe dyspnea).
Measured: From enrollment to the end of the follow-up at 11 weeks
Severity of COPD symptoms
measured by COPD Assessment Test [CAT]
Measured: From enrollment to the end of the follow-up at 11 weeks
Anxiety and depression
measured by the HAD (Hospital Anxiety and Depression) scale, minimum score of 0 (no symptoms of anxiety or depression), maximum score of 21 (severe symptoms of anxiety or depression).
Measured: From enrollment to the end of the follow-up at 11 weeks
exercise capacity
measured during an maximal exercise test
Measured: From enrollment to the end of the follow-up at 11 weeks
6 minutes walking test
measured by distance walked during 6 minutes.
Measured: From enrollment to the end of the follow-up at 11 weeks
Wakefulness after sleep onset
Wakefulness after sleep onset (WASO) measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
Sleep Efficiency
Sleep Efficiency measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
Number of awakenings
Number of awakenings measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
Micro-arousal index
Micro-arousal index measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
N1 sleep stage
N1 (%) measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
N2 sleep stage
N2 (%) measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
N3 sleep stage
N3 (%) measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
other sleep parameter
REM (%) (Rapid Eye Movement) measured by the average of the 2 independent polysomnography readings
Measured: From enrollment to the end of the follow-up at 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start19 Feb 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controled, interventional, multi center
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677268
- Sponsor's protocol ID
- 2022/0347/HP
- Acronym
- REARSOM/BPCO
- Status last verified
- Feb 2026
- First submitted
- 15 Oct 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients With Stable COPD
- ClinicalTrials.gov ID
- NCT06677268
- Acronym / sponsor ID
- REARSOM/BPCO / 2022/0347/HP
- Keywords
- polysomnography, sleep quality, physical activity, education, respiratory rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Nov 2024 (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.
COPD affects 5 to 8% of the population in France. The disease consists of inflammation of the large and small airways causing permanent obstruction of the airways and symptoms such as dyspnea, cough and sputum that worsens over time.
Among all COPD patients, 40% complain of sleep disorders. Polysomnography data showed a prolongation of sleep onset latency and a decrease in deep sleep, correlated with the severity of daytime hypoxemia. Conversely, poor sleep quality leads to an increase in dyspnea, altered quality of life and increased occurrence of COPD exacerbations.
Respiratory rehabilitation has demonstrated significant benefits on exercise capacity, dyspnea, COPD exacerbations and quality of life. To the investigators' knowledge, a few studies have investigated the relationship between physical activity and sleep quality using polysomnography in this population. Thus, the aim of the study is to evaluate the benefits of respiratory rehabilitation on sleep architecture in patients with COPD. Investigators' hypothesis is that a respiratory rehabilitation program would improve the quality of sleep measured by polysomnography. Therefore, patient with COPD and no exacerbation in the previous year will be randomly assigned to the interventional group who perform the rehabilitation program or to the control group who will not perform the program. The primary endpoint is the sleep quality estimated by total sleep time as measured by the mean of 2 independent polysomnography readings, at baseline and after the RR program in the interventional group and after 2 months of usual care in the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized, controled, interventional, multi center
| Arm | Type | Receives |
|---|---|---|
| Respiratory Rehabilitation | Experimental | Procedure: RehabilitationPatient in this arm will perform a 2-months respiratory rehabilitation program |
| Usual care | No intervention | –Patient in the control group (usual care) will have standard care without respiratory rehabilitation program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ age 50
- COPD defined according to the GOLD 2022 criteria, clinically stable (without exacerbation for at least 4 weeks), with indication for respiratory rehabilitation
- Absence of respiratory rehabilitation in the past 12 months
- Patient affiliated to the social security system
- For women of childbearing potential who have been on effective contraception (estrogen-progestogen or intrauterine device or tubal ligation) for 1 month.
Key exclusion criteria (16 listed)
- BMI≥ 30 kg/m2
- Previously documented OSA (AHI \> 10/h)
- Patient with a CPAP or NIV
- Patient on systemic corticosteroid therapy
- Patient on centrally acting therapy (benzodiazepine or opiate)
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 |
|---|---|---|
| RehabilitationPatients will undergo a respiratory rehabilitation program (24 exercise sessions of 90 minutes each, three times a week for 8 weeks and up to 9 therapeutic education workshops of 1 hour) | Procedure or surgery | Respiratory Rehabilitation |
Primary outcome
Total sleep time (TST)
Time frame: Baseline and end of respiratory rehabilitation (2 months)
measured by the average of the 2 independent polysomnography scorings
17 secondary outcomes
Sleep onset latency
Time frame: From enrollment to the end of the follow-up at 11 weeks
Pittsburgh sleep quality index (PSQI)
Time frame: From enrollment to the end of the follow-up at 11 weeks
Evolution of the quality of life
Time frame: From enrollment to the end of the follow-up at 11 weeks
Daytime sleepiness
Time frame: From enrollment to the end of the follow-up at 11 weeks
Dyspnée
Time frame: From enrollment to the end of the follow-up at 11 weeks
Severity of COPD symptoms
Time frame: From enrollment to the end of the follow-up at 11 weeks
Anxiety and depression
Time frame: From enrollment to the end of the follow-up at 11 weeks
exercise capacity
Time frame: From enrollment to the end of the follow-up at 11 weeks
6 minutes walking test
Time frame: From enrollment to the end of the follow-up at 11 weeks
Wakefulness after sleep onset
Time frame: From enrollment to the end of the follow-up at 11 weeks
Sleep Efficiency
Time frame: From enrollment to the end of the follow-up at 11 weeks
Number of awakenings
Time frame: From enrollment to the end of the follow-up at 11 weeks
Micro-arousal index
Time frame: From enrollment to the end of the follow-up at 11 weeks
N1 sleep stage
Time frame: From enrollment to the end of the follow-up at 11 weeks
N2 sleep stage
Time frame: From enrollment to the end of the follow-up at 11 weeks
N3 sleep stage
Time frame: From enrollment to the end of the follow-up at 11 weeks
other sleep parameter
Time frame: From enrollment to the end of the follow-up at 11 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease), run by University Hospital, Rouen at 4 sites in France.
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 16 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Anne Melone, MD, PhD ((+33) 0232888265, marieanne.melone@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (TST) (time frame: Baseline and end of respiratory rehabilitation (2 months)). 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 18 Feb 2026.