Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02755662
Status:
COMPLETED
Last Update Posted:
2017-09-28
First Post:
2016-04-07
Brief Title:
Clinical Impact of 2 Types of Mandibular Retention Devices - Narval ORM CadCam Design vs Narval ORM Traditional Design - on Obstructive Sleep Apnea OSA Therapy ESTAMPS Study
Sponsor:
ResMed
Organization:
ResMed
Study Overview
Official Title:
Clinical Impact of 2 Types of Mandibular Retention Devices - Narval ORM Cad Cam Design vs Narval ORM Traditional Design - on Obstructive Sleep Apnea Syndrome OSA Therapy ESTAMPS Study
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTAMPS
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
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 ORM 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 p00031 66 of CC MRD patients get a complete answer with an AHI reduction 10 vs 49 with a trad Narval MRD p00017 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None