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Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI>30) OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAD group |
| ||
| CPAP group |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance with MAD and CPAP at 6 months (wearing time). | MAD compliance at 6 months (wearing time): a sleep diary will be given to the patient at the inclusion visit. CPAP compliance at 6 months: data transmitted by the CPAP device (sleep diary). | 6 months post-inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of oral status | plaque index : values from 0 to 3. A high score is a worse outcome. | the day of inclusion |
| Assessment of oral status | mobility index : values from 1 to 4. A high score is a worse outcome. |
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Inclusion Criteria:
Target population: with coronary artery disease or at very high risk of coronary artery disease:
For the control group (CPAP): patients with moderate or severe OSA treated with CPAP.
Exclusion Criteria:
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Subjects aged over 18, suffering from moderate to severe OSA and with CV pathology or at high risk of developing it.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cindy FRANCOIS | Contact | 06 84 31 62 08 | c-francois@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de MONTPELLIER | Recruiting | Montpellier | 34090 | France |
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| the day of inclusion |
| Assessment of oral status | bleeding index : values from 0 to 1 (100%). A high score is a worse outcome. | the day of inclusion |
| Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear) | survey : values from 0 to 3. A high score is a better outcome. | 6 months post-inclusion |
| Clinical parameters of OSA (objective) | ventilatory polygraphy or polysomnography | 6 months post-inclusion |
| Assessment of quality of life | Survey WHOQOL Bref. Values : very poor, poor, neither poor nor good, good, very good. | 6 months post-inclusion |
| Clinical parameters of OSA (subjective) | Survey. Values : light, moderate, significant | 6 months post-inclusion |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D003327 | Coronary Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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