Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-01 @ 1:15 PM
Study NCT ID:
NCT05056766
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
Sponsor:
Centre Hospitalier de Valence
Organization:
Study Overview
Official Title:
How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement"
Status:
COMPLETED
Status Verified Date:
2025-09
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:
OAMMM
Brief Summary:
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence
Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).
Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.
The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.
Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).
Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.
The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.
Detailed Description:
Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method
Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: