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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

NCT ID: NCT02755662

Last Updated: 2017-09-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Narval O.R.M CC™

First mandibular retention device : Narval O.R.M CC™

Group Type ACTIVE_COMPARATOR

Mandibular Retention Device

Intervention Type DEVICE

Narval O.R.M™ trad

Second mandibular retention device : Narval O.R.M TRAD™

Group Type ACTIVE_COMPARATOR

Mandibular Retention Device

Intervention Type DEVICE

Interventions

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Mandibular Retention Device

Intervention Type DEVICE

Other Intervention Names

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Narval O.R.M CC™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Baptiste Kerbrat, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Locations

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CHU Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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RESMED Estamps 001

Identifier Type: -

Identifier Source: org_study_id