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

Obstructive Sleep Apnea Clinical Trial

— SOMNYX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112435
• Other study ID #: 14-011-CERES-D
• Secondary ID: NH-14SRP-Somnyx
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2024
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Somnyx ®
Active mandibular advancement splint
• Narval ORM ® or SomnoDent ®
Mandibular advancement splint

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Université de Montréal	Groupe Hospitalier Pitie-Salpetriere, University Hospital, Montpellier

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	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	following 3 months of treatment
Secondary	Rate of Complete Response	Rate of Complete Response (TRc) =% Patients with AHI <15 and AHI = 50% reduction and compliance = 5 nights / week and 5 hours / night)	following 3 months of treatment
Secondary	Partial response rate	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.	Following 3 months of treatment
Secondary	Subjective compliance	Subjective compliance	Following 3 months of treatment
Secondary	Sleep quality	sleep efficiency, total sleep time	Following 3 months of treatment
Secondary	Desaturation	desaturation index, time spent below 90%	Following 3 months of treatment
Secondary	Subjective sleep	Pittsburgh questionnaire	Following 3 months of treatment
Secondary	Quality of life	Functional outcomes sleep questionnaire (FOSQ)	Following 3 months of treatment
Secondary	Fatigue	Chalder fatigue questionnaire	Following 3 months of treatment
Secondary	Subjective daytime sleepiness	Epworth sleepiness score	Following 3 months of treatment
Secondary	Side effects	side effects and interactions with the dental evaluations	Following 3 months of treatment