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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01326143
First received: March 29, 2011
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention
Obstructive Sleep Apnea Syndrome
Device: ORM Narval MRD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Enrollment: 360
Study Start Date: May 2011
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ORM Narval MRD 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Severe Obstructive Sleep Apnea Hypopnea

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326143

Locations
France
Fondation Bon Sauveur / cabinet médical / cabinet dentaire
Albi, France
CH Annemasse
Annemasse, 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
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 Pitié Salpetriere
Paris, France
Hôtel Dieu
Paris, France
Hôpital Bichat Claude Bernard
Paris, France
CHU Poitiers
Poitiers, France
CHRU Rennes / polyclinique St Laurent / cabinet dentaire
Rennes, France
CHRU Rouen
Rouen, France
CHU Strasbourg / cabinet médical / cabinet dentaire
Strasbourg, France
Clinique de l'Union
Toulouse, France
CHU Toulouse
Toulouse, France
CH Valence
Valence, France
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Marie-Françoise VECCHIERINI-BLINEAU, Dr Hôtel Dieu, Paris
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01326143     History of Changes
Other Study ID Numbers: RESMED Narval ORM 001, 2010-A01121-38
Study First Received: March 29, 2011
Last Updated: March 14, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: Conseil National de l'Ordre des Chirurgiens Dentistes
France: French Data Protection Authority
France: Haute Autorité de Santé, Commission d'Evaluation des Dispositifs Médicaux et des Technologies de Santé

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

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

ClinicalTrials.gov processed this record on September 30, 2014