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

NCT02112435 | Completed

• 2 other identifiers: 14-011-CERES-DNH-14SRP-Somnyx
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; mandibular advancement splint; active mandibular advancement splint; oral appliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Rate of Complete Response

  following 3 months of treatment

• Partial response rate

  Following 3 months of treatment

• Subjective compliance

  Following 3 months of treatment

• Sleep quality

  Following 3 months of treatment

• Desaturation

  Following 3 months of treatment

Study Arms (2)

Narval ORM ® or SomnoDent ®

ACTIVE COMPARATOR

Mandibular advancement splint (Narval ORM ® or SomnoDent ®)

Device: Narval ORM ® or SomnoDent ®

Somnyx ®

EXPERIMENTAL

Active mandibular advancement splint (Somnyx ®)

Device: Somnyx ®

Interventions

Somnyx ® DEVICE

Active mandibular advancement splint

Also known as: Active mandibular advancement appliance, Oral appliance

Somnyx ®

Narval ORM ® or SomnoDent ® DEVICE

Mandibular advancement splint

Also known as: Mandibular advancement splint, Mandibular advancement appliance, Oral appliance, Mandibular repositioning appliance, Mandibular repositioning splint

Narval ORM ® or SomnoDent ®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université de Montréal: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• University Hospital, Montpellier: collaborator

Study Sites (3)

Université de Montréal

Montreal, Quebec, H3C3J7, Canada

Location

Université Montpellier

Montpellier, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Nelly Huynh, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant research professor

Study Record Dates

• First Submitted: April 5, 2014
• First Posted: April 14, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

FR (2); CA (1)