Narval CC Mandibular Repositioning Device in the Second-line Treatment of Severe Obstructive Sleep Apnea Hypopnea (OSAH) (ORCADES)

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: ORM Narval MRD

Study type: Observational

Funder types: Industry

Identifiers

NCT01326143

2010-A01121-38 (Registry Identifier)

RESMED Narval ORM 001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

360 participants in 1 patient group

ORM Narval MRD

Treatment:

Device: ORM Narval MRD