Strengthening muscles to help with moderate obstructive sleep apnea
Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
This study is testing whether a special exercise program that strengthens breathing muscles can help people with moderate sleep apnea sleep better and have fewer breathing issues at night.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 2 sites (Grenoble and 1 other locations) |
| Trial ID | NCT06471751 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with moderate obstructive sleep apnea hypopnea syndrome (OSAS) who have few or no symptoms and no cardiovascular comorbidities. It aims to evaluate the effectiveness of a rehabilitation program that strengthens the inspiratory and oropharyngeal muscles to alleviate airway obstruction during sleep. The intervention involves specific muscle training exercises designed to improve muscle tone and function. The study will assess the outcomes of this approach in improving sleep quality and reducing apnea events.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with moderate obstructive sleep apnea (AHI between 15 and 30) and a body mass index (BMI) under 35.
Not a fit: Patients with excessive daytime sleepiness, severe obstructive or restrictive ventilatory disorders, or those currently undergoing treatment for obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-invasive treatment option for patients with moderate obstructive sleep apnea, improving their quality of life.
How similar studies have performed: While this approach is relatively novel, similar studies focusing on muscle strengthening for respiratory conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Moderate SAHOS (15 ≤ AHI ≤30); * Body Mass Index (BMI) \< 35 ; * Patient affiliated or entitled to a social security scheme; * Patient having signed a consent to participate in the study. Exclusion Criteria: * Excessive daytime sleepiness: Epworth sleepiness score \> 10 ; * Professional driving and history of accidents related to sleepiness; * Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests; * Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis; * Patients who have stopped CPAP or orthosis treatment in less than one month; * Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training; * Uncompensated heart failure, thoracic sternotomy surgery \< 4 months; * Marked osteoporosis with history of rib fractures; * History of spontaneous pneumothorax; * Severe asthma;
Where this trial is running
Grenoble and 1 other locations
- CHU de Grenoble — Grenoble, France (Not_yet_recruiting)
- Centre Hospitalier Universitaire — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Amandine Zellag — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Amandine ZELLAG, physiotherapist
- Email: amandine.zellag@chu-st-etienne.fr
- Phone: (0)4 77 12 73 93
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.