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

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: ORM Narval MRD

• Registration Number: NCT01326143
• Lead Sponsor: ResMed

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Study Start: 2011-05
• Primary Completion: 2019-02
• Study Completion: 2019-02-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ORM Narval MRD	ORM Narval MRD	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Apnea/Hypopnea Index (AHI) reduced by at least 50% compared to baseline measured by Polygraphy/Polysomnography (PG/PSG)	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (25)

CHU Grenoble; 🇫🇷 Grenoble, France

Cabinet médical Lyon; 🇫🇷 Lyon, France

CH Montreuil; 🇫🇷 Montreuil, France

Clinique de l'Union; 🇫🇷 Toulouse, France

Hôpital Bichat Claude Bernard; 🇫🇷 Paris, France

CHRU Rouen; 🇫🇷 Rouen, France

Cabinet médical / cabinet dentaire; 🇫🇷 Nice, France

CHRU Montpellier / Clinique Beau Soleil / Faculté d'Odontologie / cabinet dentaire; 🇫🇷 Montpellier, France

Centre Médical Plateau de Haye / cabinet médical / cabinet dentaire; 🇫🇷 Nancy, France

Hôpital Pitié Salpetriere; 🇫🇷 Paris, France

CH Béziers; 🇫🇷 Béziers, France

Fondation Bon Sauveur / cabinet médical / cabinet dentaire; 🇫🇷 Albi, France

CH Antibes / cabinet dentaire; 🇫🇷 Antibes, France

CHU Avicennes; 🇫🇷 Bobigny, France

CHG Chalon en Champagne; 🇫🇷 Châlons-en-Champagne, France

CH Compiègne Senlis / cabinets dentaires; 🇫🇷 Compiègne, France

CHRU Lille; 🇫🇷 Lille, France

CHU La Timone / cabinet médical; 🇫🇷 Marseille, France

CH Valence; 🇫🇷 Valence, France

Polyclinique du Tondu / cabinet dentaire; 🇫🇷 Bordeaux, France

Hôtel Dieu; 🇫🇷 Paris, France

Maison de la Mutualité / polyclinique de l'Atlantique; 🇫🇷 Nantes, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHRU Rennes / polyclinique St Laurent / cabinet dentaire; 🇫🇷 Rennes, France