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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Narval ORM ® or SomnoDent ®; Device: Somnyx ®

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3C3J7
      • Université de Montréal
• France
  • Montpellier, France
    • Université Montpellier
  • Paris, France
    • Groupe Hospitalier Pitie-Salpetriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Narval ORM ® or SomnoDent ®; Mandibular advancement splint (Narval ORM ® or SomnoDent ®)	Device: Narval ORM ® or SomnoDent ®; Mandibular advancement splint; Other Names: Oral appliance; Mandibular advancement appliance; Mandibular advancement splint; Mandibular repositioning appliance; Mandibular repositioning splint
Experimental: Somnyx ®; Active mandibular advancement splint (Somnyx ®)	Device: Somnyx ®; Active mandibular advancement splint; Other Names: Oral appliance; Active mandibular advancement appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Subjective compliance	Subjective compliance	Following 3 months of treatment
Sleep quality	sleep efficiency, total sleep time	Following 3 months of treatment
Desaturation	desaturation index, time spent below 90%	Following 3 months of treatment
Subjective sleep	Pittsburgh questionnaire	Following 3 months of treatment
Quality of life	Functional outcomes sleep questionnaire (FOSQ)	Following 3 months of treatment
Fatigue	Chalder fatigue questionnaire	Following 3 months of treatment
Subjective daytime sleepiness	Epworth sleepiness score	Following 3 months of treatment
Side effects	side effects and interactions with the dental evaluations	Following 3 months of treatment

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: University Hospital, Montpellier; Groupe Hospitalier Pitie-Salpetriere
• Investigators: Principal Investigator: Nelly Huynh, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 5, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimated): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; oral appliance; mandibular advancement splint; active mandibular advancement splint
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 14-011-CERES-D; NH-14SRP-Somnyx (Other Identifier: Faculté de medecine dentaire, Université de Montreal)