Clinical trial NCT02112435: Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea
Official title: Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
mandibular advancement splint
active mandibular advancement splint
oral appliance
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
name: University Hospital, Montpellier
First posted: 2014-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall response rate
timeFrame: following 3 months of treatment
Secondary outcomes:
measure: Rate of Complete Response
timeFrame: following 3 months of treatment
measure: Partial response rate
timeFrame: Following 3 months of treatment
measure: Subjective compliance
timeFrame: Following 3 months of treatment
measure: Sleep quality
timeFrame: Following 3 months of treatment
measure: Desaturation
timeFrame: Following 3 months of treatment
measure: Subjective sleep
timeFrame: Following 3 months of treatment
measure: Quality of life
timeFrame: Following 3 months of treatment
measure: Fatigue
timeFrame: Following 3 months of treatment
measure: Subjective daytime sleepiness
timeFrame: Following 3 months of treatment
measure: Side effects
timeFrame: Following 3 months of treatment
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Université de Montréal
state: Quebec
city: Montpellier
country: France
facility: Université Montpellier
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
Study officials:
affiliation: Université de Montréal
name: Nelly Huynh, PhD
role: PRINCIPAL_INVESTIGATOR
References: