Ignite Creation Date:
2024-05-06 @ 12:14 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01524510
Status:
UNKNOWN
Last Update Posted:
2015-05-28
First Post:
2012-01-23
Brief Title:
Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Open Prospective Study for the Validation of the Predictive Value of Upper Airway Segmentation and CFD Analysis on Outcome Parameters of the Mandibular Replacement Appliance MRA Therapy in Obstructive Sleep Apnea Hypopnea Syndrome OSAHS Patients
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
In this open prospective study 40 patients who received Mandibular Replacement Appliance MRA Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome OSAHS will be included The patients sleep will be registered during 2 periods of 2 days one while the patient does not wear the MRA and - 1 week later one while the patient wears the MRA Furthermore 2 low dose CT scans one with and one without the MRA device in the mouth will be taken These data must allow the investigators to validate the use of functional imaging segmentation and Computational Fluid Dynamics as a predictor of the outcome of the MRA therapy in OSAHS patients
Detailed Description:
None
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