Status:
COMPLETED
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
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 M...
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 reducti...
Eligibility Criteria
Inclusion
- 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
- MRD contraindication
- Clinical trial classic exclusion criteria
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02755662
Start Date
May 1 2016
End Date
July 1 2017
Last Update
September 28 2017
Active Locations (1)
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1
CHU Rouen
Rouen, France