Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/3/2017 |
| Start Date: | August 2014 |
| End Date: | August 2018 |
| Contact: | Nelly Huynh, PhD |
| Email: | nelly.huynh@umontreal.ca |
Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea
Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This
disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure
(CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient
refusal or intolerance). In these cases, treatment with mandibular advancement devices can
bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of
titratable versus active mandibular advancement splints in standard care environment. This
will be based on the global response, which includes the apnea-hypopnea index and compliance
in severe apnea patients who refused or where intolerant to CPAP. Following their severe
apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement
device, follow-up visits will be scheduled after 3 months of treatment involving clinical
monitoring by a physician and a dentist.
disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure
(CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient
refusal or intolerance). In these cases, treatment with mandibular advancement devices can
bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of
titratable versus active mandibular advancement splints in standard care environment. This
will be based on the global response, which includes the apnea-hypopnea index and compliance
in severe apnea patients who refused or where intolerant to CPAP. Following their severe
apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement
device, follow-up visits will be scheduled after 3 months of treatment involving clinical
monitoring by a physician and a dentist.
Inclusion Criteria:
- age between 18 and 65 years
- severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime
sleepiness - Epworth ≥ 10 or AHI> 30
- patient in failure or refusal of CPAP treatment
- agree to participate and sign the consent form research
- speak and understand French without external assistance
- be in good health (no neurological or psychiatric syndrome).
- have a valid Social Security card (in France and Portugal only)
Exclusion Criteria:
- contra-indicated dental/periodontal states for mandibular advancement splints, such
as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized
periodontitis or severe parodonthopathies, 3) severe disorders of the
temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion
- dental restorations in progress or planned in the next 6 months
- psychiatric and neuromuscular disorders
- untreated cardiovascular diseases and history of stroke or myocardial infarction
- severe or morbid obesity (body mass index> 35)
We found this trial at
2
sites
Palo Alto, California 94304
Principal Investigator: Christian Guilleminault, MD, Biol.D
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