Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00601-46 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Association aide à la recherche médicale de proximité (AIRE) | UNKNOWN |
| Conseil national de l'ordre des masseurs-kinésithérapeutes | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strengthening muscles group | Experimental | Home training to strengthen Inspiratory and Oropharyngeal muscles |
|
| No training group | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | AHI is measured by polygraphy or polysomnography. It is not a score | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum inspiratory pressure measurement (cmH2O) | Measured by POWERbreathe® K5 | At 3 and 9 Months |
| Neck circumference (cm) | The neck circumference is measured by Magnetic Resonance Imagery (RMI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amandine ZELLAG, physiotherapist | Contact | (0)4 77 12 73 93 | +33 | amandine.zellag@chu-st-etienne.fr |
| Pierre LABEIX, physiotherapist | Contact | pierre.labeix@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Amandine Zellag | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Grenoble | Not yet recruiting | Grenoble | 38000 | France |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| At 3 months |
| Epworth sleepiness score | 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 | At 3 and 9 Months |
| Pittsburgh Sleep quality index | 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 | At 3 and 9 Months |
| Quality of life scale : Short Form 12 (SF12) | Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life | At 3 and 9 Months |
| PICOT fatigue scale | Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness | At 3 and 9 Months |
| AHI (Apnea-Hypopnea Index) | AHI is measured by polygraphy or polysomnography It is not a score | At 9 months |
| Centre Hospitalier Universitaire | Recruiting | Saint-Etienne | 42055 | France |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |