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

Obstructive Sleep Apnea Syndrome Clinical Trial

— ORCADES  

Official title:

ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326143
• Other study ID #: RESMED Narval ORM 001
• Secondary ID: 2010-A01121-38
• Status: Completed
• Start date: May 2011
• Est. completion date: February 27, 2019

Study information

• Verified date: March 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 27, 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• ORM Narval MRD

Locations

Country	Name	City	State
France	Fondation Bon Sauveur / cabinet médical / cabinet dentaire	Albi
France	CH Antibes / cabinet dentaire	Antibes
France	CH Béziers	Béziers
France	CHU Avicennes	Bobigny
France	Polyclinique du Tondu / cabinet dentaire	Bordeaux
France	CHG Chalon en Champagne	Châlons-en-Champagne
France	CH Compiègne Senlis / cabinets dentaires	Compiègne
France	CHU Grenoble	Grenoble
France	Cabinet médical / cabinet dentaire	Lagny
France	CHRU Lille	Lille
France	Cabinet médical Lyon	Lyon
France	CHU La Timone / cabinet médical	Marseille
France	CHRU Montpellier / Clinique Beau Soleil / Faculté d'Odontologie / cabinet dentaire	Montpellier
France	CH Montreuil	Montreuil
France	Centre Médical Plateau de Haye / cabinet médical / cabinet dentaire	Nancy
France	Maison de la Mutualité / polyclinique de l'Atlantique	Nantes
France	Cabinet médical / cabinet dentaire	Nice
France	Hôpital Bichat Claude Bernard	Paris
France	Hôpital Pitié Salpetriere	Paris
France	Hôtel Dieu	Paris
France	CHU Poitiers	Poitiers
France	CHRU Rennes / polyclinique St Laurent / cabinet dentaire	Rennes
France	CHRU Rouen	Rouen
France	CHU Toulouse	Toulouse
France	Clinique de l'Union	Toulouse
France	CH Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

France, 

References & Publications (2)

Attali V, Vecchierini MF, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Martin F, Tordjman F, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators. Efficacy and tolerab — View Citation

Vecchierini MF, Attali V, Collet JM, d'Ortho MP, El Chater P, Kerbrat JB, Leger D, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Meurice JC; ORCADES investigators. A custom-made mandibular repositioning device for obstructive sleep apnoea-hypop — View Citation

Outcome

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

External Links

•   ORCADES Sleep Medicine 2015