title: A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study.
abstract: Mandibular repositioning devices (MRDs) are usually recommended as the first therapy option in patients with mild-to-moderate obstructive sleep apnoea (OSA). However, data on the long-term efficacy of MRDs are limited, not only in OSA patients who are noncompliant with continuous positive airway pressure (CPAP) but also in those with more severe OSA. The ORCADES study aimed to prospectively determine the long-term efficacy and tolerability of two custom-made Narval(™) MRDs for obstructive sleep apnoea-hypopnoea syndrome (OSAHS) patients. The interim 3- to 6-month data are reported.
  
  
  
  Eligible patients had OSAHS and had refused or were noncompliant with prescribed CPAP. Outcome measurements after gradual mandibular advancement titration included: apnoea-hypopnoea index (AHI), oxygen saturation, sleepiness, symptoms, quality of life, side effects and compliance.
  
  
  
  A total of 369 patients were included. Overall, MRD treatment was successful (≥50% decrease in AHI) in 76.2% of the participants; complete response (AHI <10/h) was achieved in 63.5%. Severe OSAHS was effectively treated (AHI <15/h) in about 60% of the participants; 38% had complete symptom resolution. Mandibular repositioning devices significantly decreased subjective sleepiness, eliminated symptoms and improved quality of life. They were well tolerated and compliance was excellent. Only 8% of the participants stopped MRD treatment due to side effects.
  
  
  
  Custom-made Narval(™) MRDs are effective for mild to severe OSA in patients who refuse or are noncompliant with CPAP. They are well tolerated and have excellent compliance.
authors.affiliation: Hôpital Hôtel Dieu, Centre du Sommeil et de la Vigilance, AP-HP, Paris, France; Sorbonne Paris Cité, EA 7320 VIFASOM, Université Paris Descartes, Paris, France. Electronic address: marie-francoise.vecchierini@htd.aphp.fr.
authors.forename: Marie-Françoise
authors.initials: MF
authors.lastname: Vecchierini
authors.affiliation: Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Pathologies du Sommeil, AP-HP, Paris, France; UPMC Université Paris 06, Sorbonne Universités, UMR_S 1158, "Neurophysiologie Respiratoire Expérimentale et Clinique", Paris, France; INSERM, UMR_S 1158, "Neurophysiologie Respiratoire Expérimentale et Clinique", Paris, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Attali
authors.affiliation: Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Stomatologie et Chirurgie Maxillo-Faciale, AP-HP, Paris, France.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Collet
authors.affiliation: DHU FIRE, Hôpital Bichat-Claude Bernard, Physiologie et Explorations Fonctionnelles, AP-HP, Paris, France; Université Denis Diderot Paris 7, UFR de Médecine, Paris, France.
authors.forename: Marie-Pia
authors.initials: MP
authors.lastname: d'Ortho
authors.affiliation: Chirurgie Oto-Rhino-Laryngologie, Hôpital André Grégoire, Montreuil, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: El Chater
authors.affiliation: Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Stomatologie et Chirurgie Maxillo-Faciale, AP-HP, Paris, France; Stomatologie et Chirurgie Maxillo-Faciale, Hôpital Charles Nicolle, Rouen, France.
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Kerbrat
authors.affiliation: Hôpital Hôtel Dieu, Centre du Sommeil et de la Vigilance, AP-HP, Paris, France; Sorbonne Paris Cité, EA 7320 VIFASOM, Université Paris Descartes, Paris, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Leger
authors.affiliation: Neurophysiologie Clinique, Hôpital Roger Salengro, Lille, France.
authors.forename: Christelle
authors.initials: C
authors.lastname: Monaca
authors.affiliation: Oto-Rhino-Laryngologie, Polyclinique du Tondu, Bordeaux, France.
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Monteyrol
authors.affiliation: ResMed Science Center, Saint Priest cedex, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Morin
authors.affiliation: Laboratoire du Sommeil, Fondation Bon Sauveur, Albi, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Mullens
authors.affiliation: Laboratoire du Sommeil, Nice, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Pigearias
authors.affiliation: Pneumologie, Centre Hospitalier Universitaire, Poitiers, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Meurice
mesh_terms: D045422:Continuous Positive Airway Pressure; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D019186:Mandibular Advancement / Q000295:instrumentation*; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology; D011446:Prospective Studies; D011788:Quality of Life; D020181:Sleep Apnea, Obstructive / Q000628:therapy*
keywords: Compliance; Mandibular repositioning device; Obstructive sleep apnoea; Tolerance