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| Name | Class |
|---|---|
| ResMed | INDUSTRY |
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The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence
Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).
Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.
The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.
Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method
Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group assignement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire. | Behavioral | Each patient will undergo 3 to 7 polygraphy recordings according usual practice of titration At the same time, Self-questionnaires will be conducted by the patient in order to evaluate Oral appliance efficacy. Optimal titration of oral appliance will be done according subjectives parameters. (sleepeness Reduction and fatigue Reduction). Neither the investigator nor the patient will know the polygraphy results (apnea-hypopnea index) |
| Measure | Description | Time Frame |
|---|---|---|
| apnea-hypopnea index | severity of sleep apnea | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale score | 6 months | |
| pichot fatigue questionnaire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients, with primary Moderate sleep apnea or Severe sleep apnea with failure continuous positive airway pressure( CPAP).
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume BUIRET, MD | CH VALENCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Valence | Valence | 26953 | France |
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|
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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