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Sleep Med. 2016 Mar;19:131-40. doi: 10.1016/j.sleep.2015.05.020. Epub 2015 Jun 29.

A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study.

Author information

1
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.
2
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.
3
Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Stomatologie et Chirurgie Maxillo-Faciale, AP-HP, Paris, France.
4
DHU FIRE, Hôpital Bichat-Claude Bernard, Physiologie et Explorations Fonctionnelles, AP-HP, Paris, France; Université Denis Diderot Paris 7, UFR de Médecine, Paris, France.
5
Chirurgie Oto-Rhino-Laryngologie, Hôpital André Grégoire, Montreuil, France.
6
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.
7
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.
8
Neurophysiologie Clinique, Hôpital Roger Salengro, Lille, France.
9
Oto-Rhino-Laryngologie, Polyclinique du Tondu, Bordeaux, France.
10
ResMed Science Center, Saint Priest cedex, France.
11
Laboratoire du Sommeil, Fondation Bon Sauveur, Albi, France.
12
Laboratoire du Sommeil, Nice, France.
13
Pneumologie, Centre Hospitalier Universitaire, Poitiers, France.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:

Compliance; Mandibular repositioning device; Obstructive sleep apnoea; Tolerance

PMID:
26364869
DOI:
10.1016/j.sleep.2015.05.020
[Indexed for MEDLINE]
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