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

NCT02112435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-29

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Somnyx ®

Active mandibular advancement splint

DEVICE

Narval ORM ® or SomnoDent ®

Mandibular advancement splint

Sponsors & Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

    collaborator OTHER

  • University Hospital, Montpellier

    collaborator OTHER

  • Université de Montréal

    lead OTHER

Principal Investigators

  • Nelly Huynh, PhD · Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada
  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112435 on ClinicalTrials.gov