Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, mandibular advancement splint, active mandibular advancement splint, oral appliance
Brief summary
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.
Interventions
DEVICESomnyx ®
Active mandibular advancement splint
DEVICENarval ORM ® or SomnoDent ®
Mandibular advancement splint
Sponsors
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Montpellier
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | following 3 months of treatment | Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI \<15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial response rate | Following 3 months of treatment | Partial response rate =% of patients with reduction AHI ≥ 50% with AHI\> 15 or AHI \<15 with reduction \<50% and adherence ≥ 5 nights / week and 5 hours / night) at 3 months of treatment. |
| Subjective compliance | Following 3 months of treatment | Subjective compliance |
| Sleep quality | Following 3 months of treatment | sleep efficiency, total sleep time |
| Desaturation | Following 3 months of treatment | desaturation index, time spent below 90% |
| Rate of Complete Response | following 3 months of treatment | Rate of Complete Response (TRc) =% Patients with AHI \<15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night) |
| Quality of life | Following 3 months of treatment | Functional outcomes sleep questionnaire (FOSQ) |
| Fatigue | Following 3 months of treatment | Chalder fatigue questionnaire |
| Subjective daytime sleepiness | Following 3 months of treatment | Epworth sleepiness score |
| Side effects | Following 3 months of treatment | side effects and interactions with the dental evaluations |
| Subjective sleep | Following 3 months of treatment | Pittsburgh questionnaire |
Countries
Canada, France
Outcome results
None listed