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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01326143
Recruitment Status : Active, not recruiting
First Posted : March 30, 2011
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Syndrome 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
Actual Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH
Study Start Date : May 2011
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe Obstructive Sleep Apnea Hypopnea

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326143

Fondation Bon Sauveur / cabinet médical / cabinet dentaire
Albi, France
CH Antibes / cabinet dentaire
Antibes, France
CHU Avicennes
Bobigny, France
Polyclinique du Tondu / cabinet dentaire
Bordeaux, France
CH Béziers
Béziers, France
CHG Chalon en Champagne
Chalon 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, France
Sponsors and Collaborators
Principal Investigator: Marie-Françoise VECCHIERINI-BLINEAU, Dr Hôtel Dieu, Paris

Additional Information:
Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01326143     History of Changes
Other Study ID Numbers: RESMED Narval ORM 001
2010-A01121-38 ( Registry Identifier: ID RCB AFSSAPS )
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by ResMed:
Oral appliance
Obstructive Sleep apnea
OSA treatment

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases