Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Other: Inspiratory and Oropharyngeal Muscle Strengthening
- Registration Number
- NCT06471751
- Brief 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.
- Detailed Description
For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 38
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Strengthening muscles group Inspiratory and Oropharyngeal Muscle Strengthening Home training to strengthen Inspiratory and Oropharyngeal muscles
- Primary Outcome Measures
Name Time Method Apnea-Hypopnea Index (AHI) At 3 months AHI is measured by polygraphy or polysomnography. It is not a score
- Secondary Outcome Measures
Name Time Method Maximum inspiratory pressure measurement (cmH2O) At 3 and 9 Months Measured by POWERbreathe® K5
Neck circumference (cm) At 3 months The neck circumference is measured by Magnetic Resonance Imagery (RMI)
Epworth sleepiness score At 3 and 9 Months Sleep quality assessment using the Epworth sleepiness score. From 0 to 24. If score up to 10 then the patient has signs of excessive daytime sleepiness
Pittsburgh Sleep quality index At 3 and 9 Months Sleep quality assessment using the Pittsburgh Sleep quality index. From 0 to 21. Score 0 = very good sleep quality. Score 21 = very poor sleep quality
Quality of life scale : Short Form 12 (SF12) At 3 and 9 Months Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life
PICOT fatigue scale At 3 and 9 Months Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness
AHI (Apnea-Hypopnea Index) At 9 months AHI is measured by polygraphy or polysomnography It is not a score
Trial Locations
- Locations (2)
CHU de Grenoble
🇫🇷Grenoble, France
Centre Hospitalier Universitaire
🇫🇷Saint-Étienne, France