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

Last updated: March 27, 2024
Sponsor: Université de Montréal
Overall Status: Completed

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Somnyx ®

Narval ORM ® or SomnoDent ®

Clinical Study ID

NCT02112435
14-011-CERES-D
NH-14SRP-Somnyx
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age between 18 and 65 years
  • severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytimesleepiness - 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

Exclusion Criteria:

  • contra-indicated dental/periodontal states for mandibular advancement splints, suchas: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalizedperiodontitis or severe parodonthopathies, 3) severe disorders of thetemporomandibular 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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Somnyx ®
Phase:
Study Start date:
August 01, 2014
Estimated Completion Date:
December 31, 2018

Connect with a study center

  • Université de Montréal

    Montreal, Quebec H3C3J7
    Canada

    Site Not Available

  • Polyclinique du Tondu

    Bordeaux,
    France

    Site Not Available

  • Université Montpellier

    Montpellier,
    France

    Site Not Available

  • Groupe Hospitalier Pitie-Salpetriere

    Paris,
    France

    Site Not Available

  • Hospital CUF Porto

    Porto,
    Portugal

    Site Not Available

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

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