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

Study Overview
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Brief Summary
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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
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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).

Official Title
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ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: ORM Narval MRD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ORM Narval MRD<br> | Device: ORM Narval MRD<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Fatigue score (Pichot questionaire) |  | 3 months, 2 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRD, Narval, Oral appliance, Obstructive Sleep apnea, OSAH, OSA treatment