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

NCT02112435 — Not applicable, Completed, 100 participants, Université de Montréal

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Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea

Registry	NCT02112435, acronym SOMNYX
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Université de Montréal (Other); collaborators: Groupe Hospitalier Pitie-Salpetriere, University Hospital, Montpellier
Conditions	Obstructive Sleep Apnea
Interventions	Somnyx ®, Narval ORM ® or SomnoDent ® (Device)
Dates	start 2014-08-01, primary completion 2018-12-01, completion 2018-12-01, first posted 2014-04-14, last updated 2024-03-29
Locations	3 sites in Canada, France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Narval ORM ® or SomnoDent ®	Active comparator	Device: Narval ORM ® or SomnoDent ®	Mandibular advancement splint (Narval ORM ® or SomnoDent ®)
Somnyx ®	Experimental	Device: Somnyx ®	Active mandibular advancement splint (Somnyx ®)

Somnyx ® (Device), also known as Active mandibular advancement appliance, Oral appliance: Active mandibular advancement splint
Narval ORM ® or SomnoDent ® (Device), also known as Mandibular advancement splint, Mandibular advancement appliance, Oral appliance, Mandibular repositioning appliance, Mandibular repositioning splint: Mandibular advancement splint

+Outcome measures

Primary outcomes

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 outcomes

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)
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%
Subjective sleep [Following 3 months of treatment]: Pittsburgh questionnaire
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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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)

+Locations (3)

Facility	City	Country
Université de Montréal	Montreal, Quebec	Canada
Université Montpellier	Montpellier	France
Groupe Hospitalier Pitie-Salpetriere	Paris	France

+Investigators

Nelly Huynh, PhD, Principal investigator, Université de Montréal

My Notes

Public

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