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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: Mandibular Retention Device

• Registration Number: NCT02755662
• Lead Sponsor: ResMed

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

Study Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Study Start: 2016-05
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Narval O.R.M CC™	Mandibular Retention Device	First mandibular retention device : Narval O.R.M CC™
Narval O.R.M™ trad	Mandibular Retention Device	Second mandibular retention device : Narval O.R.M TRAD™

Primary Outcome Measures

Name	Time	Method
upper airway volume	1 month	investigators will measure upper airway volume (cm3) changes produced by 2 different Mandibular Retention Devices in Obstructive sleep apnea syndrome (OSA) patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Rouen; 🇫🇷 Rouen, France