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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Narval ORM ® or SomnoDent ®; Device: Somnyx ®

• Registration Number: NCT02112435
• Lead Sponsor: Université de Montréal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-05
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-14
• Study Start: 2014-08
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narval ORM ® or SomnoDent ®	Narval ORM ® or SomnoDent ®	Mandibular advancement splint (Narval ORM ® or SomnoDent ®)
Somnyx ®	Somnyx ®	Active mandibular advancement splint (Somnyx ®)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sleep quality	Following 3 months of treatment	sleep efficiency, total sleep time
Subjective daytime sleepiness	Following 3 months of treatment	Epworth sleepiness score
Desaturation	Following 3 months of treatment	desaturation index, time spent below 90%
Side effects	Following 3 months of treatment	side effects and interactions with the dental evaluations
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)
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
Subjective sleep	Following 3 months of treatment	Pittsburgh questionnaire
Fatigue	Following 3 months of treatment	Chalder fatigue questionnaire

Trial Locations

Locations (3)

Université Montpellier; 🇫🇷 Montpellier, France

Groupe Hospitalier Pitie-Salpetriere; 🇫🇷 Paris, France

Université de Montréal; 🇨🇦 Montreal, Quebec, Canada