Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Narval ORM ® or SomnoDent ®

Mandibular advancement splint (Narval ORM ® or SomnoDent ®)

Group Type ACTIVE_COMPARATOR

Narval ORM ® or SomnoDent ®

Intervention Type DEVICE

Mandibular advancement splint

Somnyx ®

Active mandibular advancement splint (Somnyx ®)

Group Type EXPERIMENTAL

Somnyx ®

Intervention Type DEVICE

Active mandibular advancement splint

Interventions

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Somnyx ®

Active mandibular advancement splint

Intervention Type DEVICE

Narval ORM ® or SomnoDent ®

Mandibular advancement splint

Intervention Type DEVICE

Other Intervention Names

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Active mandibular advancement appliance Oral appliance Mandibular advancement splint Mandibular advancement appliance Oral appliance Mandibular repositioning appliance Mandibular repositioning splint

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No