Clinical trial NCT01326143: Narval CC Mandibular Repositioning Device in the Second-line Treatment of Severe Obstructive Sleep Apnea Hypopnea (OSAH)
Official title: ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: MRD
Narval
Oral appliance
Obstructive Sleep apnea
OSAH
OSA treatment
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe Obstructive Sleep Apnea Hypopnea

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.

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 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

Primary outcomes:
measure: Percentage of patients with Apnea/Hypopnea Index (AHI) reduced by at least 50% compared to baseline measured by Polygraphy/Polysomnography (PG/PSG)
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of patients with AHI reduced by at least 50% compared to baseline measured by PG/PSG
timeFrame: 3 months and 2 years
measure: Percentage of patients who no longer suffer from severe daytime sleepiness (Epworth Sleepiness scale)
timeFrame: 3 months, 2 years and 5 years
measure: Sleep quality of life (Quebec Sleep Questionaire)
timeFrame: 3 months, 2 years and 5 years
measure: Percentage of patients who stopped the therapy for dento-maxillofacial side effects
timeFrame: 6 months, 1, 2, 3, 4 and 5 years
measure: Percentage of patients with satisfactory compliance
timeFrame: 3 months, 2 and 5 years.
measure: Fatigue score (Pichot questionaire)
timeFrame: 3 months, 2 and 5 years
Other outcomes:
Locations:
city: Albi
country: France
facility: Fondation Bon Sauveur / cabinet médical / cabinet dentaire
city: Antibes
country: France
facility: CH Antibes / cabinet dentaire
city: Bobigny
country: France
facility: CHU Avicennes
city: Bordeaux
country: France
facility: Polyclinique du Tondu / cabinet dentaire
city: Béziers
country: France
facility: CH Béziers
city: Châlons-en-Champagne
country: France
facility: CHG Chalon en Champagne
city: Compiègne
country: France
facility: CH Compiègne Senlis / cabinets dentaires
city: Grenoble
country: France
facility: CHU Grenoble
city: Lagny
country: France
facility: Cabinet médical / cabinet dentaire
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Cabinet médical Lyon
city: Marseille
country: France
facility: CHU La Timone / cabinet médical
city: Montpellier
country: France
facility: CHRU Montpellier / Clinique Beau Soleil / Faculté d'Odontologie / cabinet dentaire
city: Montreuil
country: France
facility: CH Montreuil
city: Nancy
country: France
facility: Centre Médical Plateau de Haye / cabinet médical / cabinet dentaire
city: Nantes
country: France
facility: Maison de la Mutualité / polyclinique de l'Atlantique
city: Nice
country: France
facility: Cabinet médical / cabinet dentaire
city: Paris
country: France
facility: Hôpital Bichat Claude Bernard
city: Paris
country: France
facility: Hôpital Pitié Salpetriere
city: Paris
country: France
facility: Hôtel Dieu
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHRU Rennes / polyclinique St Laurent / cabinet dentaire
city: Rouen
country: France
facility: CHRU Rouen
city: Toulouse
country: France
facility: CHU Toulouse
city: Toulouse
country: France
facility: Clinique de l'Union
city: Valence
country: France
facility: CH Valence
Study officials:
affiliation: Hôtel Dieu, Paris
name: Marie-Françoise VECCHIERINI-BLINEAU, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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-hypopnoea syndrome: the ORCADES study. Sleep Med. 2016 Mar;19:131-40. doi: 10.1016/j.sleep.2015.05.020. Epub 2015 Jun 29.
citation: 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.
citation: 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.