Narval CC Mandibular Repositioning Device in the Second-line Treatment of Severe Obstructive Sleep Apnea Hypopnea (OSAH)
NCT ID: NCT01326143
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
360 participants
OBSERVATIONAL
2011-05-31
2019-02-27
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ORM Narval MRD
ORM Narval MRD
Interventions
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ORM Narval MRD
Eligibility Criteria
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Inclusion Criteria
* 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
* \> 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
18 Years
ALL
No
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-Françoise VECCHIERINI-BLINEAU, Dr
Role: PRINCIPAL_INVESTIGATOR
Hôtel Dieu, Paris
Locations
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Fondation Bon Sauveur / cabinet médical / cabinet dentaire
Albi, , France
CH Antibes / cabinet dentaire
Antibes, , France
CH Béziers
Béziers, , France
CHU Avicennes
Bobigny, , France
Polyclinique du Tondu / cabinet dentaire
Bordeaux, , France
CHG Chalon en Champagne
Châlons-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
Countries
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References
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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.
Other Identifiers
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2010-A01121-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
RESMED Narval ORM 001
Identifier Type: -
Identifier Source: org_study_id
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