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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Centre Hospitalier Universitaire de Saint Etienne • ClinicalTrials.gov ID: NCT06471751

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Inspiratory and Oropharyngeal Muscle Strengthening (Other)
    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.

Eligibility 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; * 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).

Conditions

Obstructive Sleep Apnea

Locations

  • CHU de Grenoble — Grenoble, France
  • Centre Hospitalier Universitaire — Saint-Etienne, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record