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| ID | Type | Description | Link |
|---|---|---|---|
| JDBF-2012 | Other Grant/Funding Number | JD Begin foundation |
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Inability to further include additional patients
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CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.
Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oro-nasal mask | Active Comparator | Oro-nasal mask during 1 month of auto CPAP |
|
| Nasal mask and oral appliance | Experimental | Nasal mask and oral appliance during 1 month of auto CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| CPAP compliance | CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition. | After 4 weeks of CPAP trial |
| Measure | Description | Time Frame |
|---|---|---|
| diurnal somnolence | Epworth Sleepiness Score | After 4 weeks of CPAP trial |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory disturbances index | Provided by CPAP report | After 4 weeks of CPAP trial |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic Series, MD | Fondation IUCPQ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUM | Montreal | Quebec | Canada | |||
| IUCPQ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23691209 | Background | Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP). Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013. | |
| 30689098 |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Québec |
| G1V 4G5 |
| Canada |
| AGIRADOM | Grenoble | France |
| Derived |
| Leotard A, Lesgoirres M, Daabek N, Lebret M, Bailly S, Verain A, Series F, Pepin JL, Borel JC. Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial. Sleep Breath. 2019 Sep;23(3):885-888. doi: 10.1007/s11325-018-01772-5. Epub 2019 Jan 28. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |