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Clinical Trials in France / NCT06471751
Recruiting Not applicable

Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome

NCT06471751 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-12-30
Last updated
2026-09-25

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Inspiratory and Oropharyngeal Muscle Strengthening

Inspiratory and Oropharyngeal Muscle Strengthening: Patients will conduct the training at home, 5 days a week for 3 months. They will perform 2 sets of 30 inspirations against resistance (POWERbreathe® K5 , Powerbreathe International Limited, UK), equal to 70% Maximum Inspiratory Pressure (MIP). Patients will be guided for oropharyngeal exercises. The sessions will be supervised by the investigator every 3 weeks. During sessions with the investigator, sessions recorded in the device will be downloaded to verify compliance. A MIP measurement will be performed to adjust the resistance of the device.

Study summary

The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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; * Perforated eardrum or any other ear condition; * Pulmonary hypertension; * History of pharyngeal surgery to treat sleep apnea; * Pregnant women or women in labor; * Individuals deprived of their liberty or hospitalized without consent; * Adults subject to legal protective measures (guardianship or conservatorship). Contraindications for MRI * Patient with claustrophobia; * Patient for whom MRI is contraindicated (pacemaker, metallic heart valve, metallic foreign body in the eye).

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
CHU de Grenoble Grenoble France Not Yet Recruiting
Centre Hospitalier Universitaire Saint-Etienne France Recruiting

More Centre Hospitalier Universitaire de Saint Etienne trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06471751 on ClinicalTrials.gov ↗ ← All trials in France