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 (ESTAMPS)

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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Mandibular Retention Device

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • CHU Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Narval O.R.M CC™; First mandibular retention device : Narval O.R.M CC™	Device: Mandibular Retention Device; Other Names: Narval O.R.M CC™
Active Comparator: Narval O.R.M™ trad; Second mandibular retention device : Narval O.R.M TRAD™	Device: Mandibular Retention Device; 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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Jean-Baptiste Kerbrat, MD, CHU Rouen

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea Syndrome; mandibular repositioning device
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: RESMED Estamps 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO