Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424405
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-12
Brief Title:
A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients
Sponsor:
Beijing Jishuitan Hospital
Organization:
Beijing Jishuitan Hospital
Study Overview
Official Title:
A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The aim of this clinical trial is to apply a new objective titration procedure in obstructive sleep apnea hypopnea syndrome OSAHS patients treated with mandibular advancement device MAD and to compare this new objective titration procedure with the subjective titration procedure which is commonly used in clinical practice The remotely intelligent sleep monitoring system RISMS will be used in the new objective titration procedure The main questions it aims to answer are
1 The efficacy of MAD therapy after each titration procedure
2 The titration time efficiency and the improvement of subjective symptoms after each titration procedure
1 The efficacy of MAD therapy after each titration procedure
2 The titration time efficiency and the improvement of subjective symptoms after each titration procedure
Detailed Description:
In this study patients diagnosed with OSAHS and referred for MAD treatment will be recruited The amount of mandibular protrusion seems to be a key factor in the treatment of MAD Patients will experience either of the two titration procedures to obtain the optimal mandibular protrusion One procedure is a new objective titration procedure which will use the RISMS for the treatment of MAD which will help the clinician instruct the titration according the objective therapeutic indicator The other procedure is the subjective titration procedure which is commonly used in clinical practice Finally the researchers will compare the efficacy of the MAD therapy the titration time efficiency and the improvement of subjective symptoms between the two titration procedures
Study Oversight
Has Oversight DMC:
None
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?:
None