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New treatment option for COPD (Chronic Obstructive Pulmonary Disease)
Official title Respiratory Rehabilitation and Sleep Quality in COPD Patients
ClinicalTrials.gov ID: NCT06677268
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Le Havre, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Le Havre, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.