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

NCT01326143 | Completed

• 2 other identifiers: RESMED Narval ORM 0012010-A01121-38
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 26

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

MRD; Narval; Oral appliance; Obstructive Sleep apnea; OSAH; OSA treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Study Arms (1)

ORM Narval MRD

Device: ORM Narval MRD

Interventions

ORM Narval MRD DEVICE

ORM Narval MRD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe Obstructive Sleep Apnea Hypopnea

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (26)

Fondation Bon Sauveur / cabinet médical / cabinet dentaire

Albi, France

Location

CH Antibes / cabinet dentaire

Antibes, France

Location

CH Béziers

Béziers, France

Location

CHU Avicennes

Bobigny, France

Location

Polyclinique du Tondu / cabinet dentaire

Bordeaux, France

Location

CHG Chalon en Champagne

Châlons-en-Champagne, France

Location

CH Compiègne Senlis / cabinets dentaires

Compiègne, France

Location

CHU Grenoble

Grenoble, France

Location

Cabinet médical / cabinet dentaire

Lagny, France

Location

CHRU Lille

Lille, France

Location

Cabinet médical Lyon

Lyon, France

Location

CHU La Timone / cabinet médical

Marseille, France

Location

CHRU Montpellier / Clinique Beau Soleil / Faculté d'Odontologie / cabinet dentaire

Montpellier, France

Location

CH Montreuil

Montreuil, France

Location

Centre Médical Plateau de Haye / cabinet médical / cabinet dentaire

Nancy, France

Location

Maison de la Mutualité / polyclinique de l'Atlantique

Nantes, France

Location

Cabinet médical / cabinet dentaire

Nice, France

Location

Hôpital Bichat Claude Bernard

Paris, France

Location

Hôpital Pitié Salpetriere

Paris, France

Location

Hôtel Dieu

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHRU Rennes / polyclinique St Laurent / cabinet dentaire

Rennes, France

Location

CHRU Rouen

Rouen, France

Location

CHU Toulouse

Toulouse, France

Location

Clinique de l'Union

Toulouse, France

Location

CH Valence

Valence, France

Location

Related Publications (3)

• 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.

  PMID: 26364869 RESULT

• 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.

  PMID: 31606651 RESULT

• 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.

  PMID: 30580418 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marie-Françoise VECCHIERINI-BLINEAU, Dr

  Hôtel Dieu, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2019
• Study Completion: February 27, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

FR (26)