Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M CadCam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea (OSA) Therapy: ESTAMPS Study

Study Overview
=================
Brief Summary
-----------------
ESTAMPS is a randomized clinical trial with a crossover design: Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway volume secondary objectives: To evaluate the maximal mandibular propulsion according to the type of MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on mandibular positioning

Detailed Description
-----------------
Hypothesis ORCADES results suggest that Narval O.R.M CC could be more efficient than Narval MRD trad to reduce AHI whatever the initial OSA severity 79% of CC MRD patients have at least an AHI reduction of 50% (vs. 61% with a trad Narval MRD, p=0.0031) 66% of CC MRD patients get a complete answer with an AHI reduction <10 (vs. 49% with a trad Narval MRD, p=0.0017) The investigators think that differences seen in the ORCADES study between the 2 MRD is due to a different impact on upper airway volume

Official Title
-----------------
Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M Cad Cam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea Syndrome (OSA) Therapy: ESTAMPS Study

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: Mandibular Retention Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a mild OSA syndrome (5<AHI<30) and mild to moderate sleepiness without cardiac comorbidities or patients with mild to severe OSA syndrome (IAH>15) who do not tolerate or refuse CPAP therapy Patients ≥ 18 years old Patient is able to fully understand study information and provide written informed consent Exclusion Criteria: MRD contraindication Clinical trial classic exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narval O.R.M CC™<br>First mandibular retention device : Narval O.R.M CC™ | Device: Mandibular Retention Device<br> <br> * Other names: Narval O.R.M CC™;|
| Active Comparator: Narval O.R.M™ trad<br>Second mandibular retention device : Narval O.R.M TRAD™ | Device: Mandibular Retention Device<br> <br> * Other names: Narval O.R.M CC™;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper airway volume | investigators will measure upper airway volume (cm3) changes produced by 2 different Mandibular Retention Devices in Obstructive sleep apnea syndrome (OSA) patients | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal mandibular propulsion | investigators will measure the maximal mandibular propulsion (in millimeter) at the end of MRD titration | 1 month | 
| quality of sleep | investigators will use specific quality of sleep questionnaire: Pittsburgh sleep quality index (PSQI), | 1 month | 
| sleepiness | investigators will use a specific sleepiness questionnaire: Epworth sleepiness scale (ESS) | 1 month | 
| MRD therapy efficacy | investigators will measure the residual Apnea and Hypopnea Index (AHI) via polygraphy | 1 month | 
| mandibular positioning | investigators will measure the mandibular positioning under MRD therapy (in millimeter) | 1 month | 
| Occlusal vertical dimension | investigators will measure the occlusal vertical dimension changes (in millimeter) between the 2 type of MRD | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea Syndrome, mandibular repositioning device