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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: ORM Narval MRD

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 Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Severe Obstructive Sleep Apnea Hypopnea

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ORM Narval MRD	Device: ORM Narval MRD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 who no longer suffer from severe daytime sleepiness (Epworth Sleepiness scale)	3 months, 2 years and 5 years
Sleep quality of life (Quebec Sleep Questionaire)	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 satisfactory compliance	3 months, 2 and 5 years.
Fatigue score (Pichot questionaire)	3 months, 2 and 5 years

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Marie-Françoise VECCHIERINI-BLINEAU, Dr, Hôtel Dieu, Paris

Publications and helpful links

General Publications

• 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-hypopnoea syndrome: the ORCADES study. Sleep Med. 2016 Mar;19:131-40. doi: 10.1016/j.sleep.2015.05.020. Epub 2015 Jun 29.
• 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 tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data. Sleep Med. 2019 Nov;63:64-74. doi: 10.1016/j.sleep.2019.04.021. Epub 2019 Jun 12.
• Vecchierini MF, Attali V, 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, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators; Abedipour D, Allard-Redon A, Aranda A, Attali V, Bavozet F, Becu M, Beruben W, Bessard J, Bonafe I, Boukhana M, Chabrol B, Chatte G, Lebret C, Collet JM, Coste O, Dumont N, Durand-Amat S, D'ortho MP, Elbaum JM, De Santerre OG, Goutorbes F, Grandjean T, Guyot W, Hammer D, Havasi C, Huet P, Kerbrat JB, Khemliche H, Koltes C, Leger D, Lacassagne L, Laur X, Lerousseau L, Liard O, Loisel C, Longuet M, Mallart A, Martin F, Merle Beral F, Meurice JC, Mokhtari Z, Monaca C, Monteyrol PJ, Muir JF, Mullens E, Muller D, Paoli C, Petit FX, Pigearias B, Pradines M, Prigent A, Putterman G, Rey M, Samama M, Tamisier R, Tiberge M, Tison C, Tordjman F, Triolet B, Vacher C, Vecchierini MF, Verain A. Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome. Sleep Breath. 2019 Sep;23(3):837-848. doi: 10.1007/s11325-018-1766-8. Epub 2018 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 27, 2019

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: OSAH; MRD; Obstructive Sleep apnea; Oral appliance; Narval; OSA treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: RESMED Narval ORM 001; 2010-A01121-38 (Registry Identifier: ID RCB AFSSAPS)