Obstructive Sleep Apnea
Conditions
Keywords
Inspiratory Muscles Training, Oropharyngeal training
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.
Interventions
OTHERInspiratory 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.
Sponsors
Association aide à la recherche médicale de proximité (AIRE)
Conseil national de l'ordre des masseurs-kinésithérapeutes
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | At 3 months | AHI is measured by polygraphy or polysomnography. It is not a score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Maximum inspiratory pressure measurement (cmH2O) | At 3 and 9 Months | Measured by POWERbreathe® K5 |
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactAmandine ZELLAG, physiotherapist
Backup ContactPierre LABEIX, physiotherapist
Outcome results
None listed