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

NCT02755662 | Completed

• 1 other identifier: RESMED Estamps 001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome; mandibular repositioning device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• maximal mandibular propulsion

  1 month

• quality of sleep

  1 month

• sleepiness

  1 month

• MRD therapy efficacy

  1 month

• mandibular positioning

  1 month

Study Arms (2)

Narval O.R.M CC™

ACTIVE COMPARATOR

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

Device: Mandibular Retention Device

Narval O.R.M™ trad

ACTIVE COMPARATOR

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

Device: Mandibular Retention Device

Interventions

Mandibular Retention Device DEVICE

Also known as: Narval O.R.M CC™

Narval O.R.M CC™; Narval O.R.M™ trad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• MRD contraindication

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

CHU Rouen

Rouen, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Baptiste Kerbrat, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)