Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea syndrome
Treatment orm narval mrd
Sponsor ResMed
Start date May 2011
End date May 2019
Trial size 360 participants
Trial identifier NCT01326143, 2010-A01121-38, RESMED Narval ORM 001

Summary

The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to Continuous Positive Airway Pressure (CPAP) treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
orm narval mrd

Primary Outcomes

Measure
Percentage of patients with Apnea/Hypopnea Index (AHI) reduced by at least 50% compared to baseline measured by Polygraphy/Polysomnography (PG/PSG)
time frame: 5 years

Secondary Outcomes

Measure
Percentage of patients with AHI reduced by at least 50% compared to baseline measured by PG/PSG
time frame: 3 months and 2 years
Percentage of patients who no longer suffer from severe daytime sleepiness (Epworth Sleepiness scale)
time frame: 3 months, 2 years and 5 years
Sleep quality of life (Quebec Sleep Questionaire)
time frame: 3 months, 2 years and 5 years
Percentage of patients who stopped the therapy for dento-maxillofacial side effects
time frame: 6 months, 1, 2, 3, 4 and 5 years
Percentage of patients with satisfactory compliance
time frame: 3 months, 2 and 5 years.
Fatigue score (Pichot questionaire)
time frame: 3 months, 2 and 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patient with severe OSAH (AHI > 30 or AHI of between 5 and 30 along with severe daytime sleepiness), - intolerant to or having refused CPAP therapy, - no dental, parodontal or articulatory contraindications, - no experience of any mandibular advancement device therapy, - medical insurance. Exclusion Criteria: - severe psychiatric disorders or severe neuromuscular disorders - > 20% of central apneas during the baseline assessment, - severe OSAH with an AHI > 30 associated with another sleep pathology (narcolepsy with or without cataplexy, idiopathic hypersomnia, severe restless legs syndrome), - pregnant or breastfeeding woman, - Informed consent not signed, - patient requiring special protection such as patients with appointed guardians and patients without legal or administrative rights, - patient who is completely or partially edentulous

Additional Information

Official title ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH
Principal investigator Marie-Françoise VECCHIERINI-BLINEAU, Dr
Description OSAH is a common condition which occurs in between 1 and 4% of the adult population. Respiratory obstruction may be complete (apnea) or incomplete (hypopnea). This disorder disturbs the architecture and quality of sleep, and is a known risk factor in the development of cardiovascular and metabolic diseases. CPAP is the standard treatment, however in some cases patients are unable to use it (rejection, intolerance, etc.). In such circumstances, treatment using a MRD may result in an improvement of symptoms. Very few long-term clinical data are available on treatment of OSAH by MRD. This study should allow to have a precise and representative vision of 5 years results of ORM Narval MRD treatment in conditions of good practices (titration, controls of efficacy).
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by ResMed.