NCT06424405

A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients

A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Jishuitan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Interventions

Type	Name	Description
PROCEDURE	titration procedure for MAD treatment	The OSAHS patients referred for MAD treatment will experience either the objective titration procedure or the subjective titration procedure.

Timeline

• Start date: 2024-04-25
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2024-05-22
• Last updated: 2024-05-22

Locations

1 site across 1 country: China