RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - OSAHS patients with AHI≥15 - 18≤age≤70 years; - Subject is capable of giving willing to sign a consent form - refusal of or noncompliance with CPAP (continuous positive airway pressure) or unwilling to undergo upper airway surgery - Normal clinical, periodontal and temporomandibular joint examination Who Should NOT Join This Trial: - Active periodontal problems including tooth mobility - active temporomandibular joint dysfunction - Edentulous patients or Insufficient teeth to support MAD - patients with severe unstable systemic diseases or suffering from psychiatric disorders - Enlarged palatine tonsils (Friedman grade IV tonsils) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * OSAHS patients with AHI≥15 * 18≤age≤70 years; * Subject is capable of giving informed consent * refusal of or noncompliance with CPAP (continuous positive airway pressure) or unwilling to undergo upper airway surgery * Normal clinical, periodontal and temporomandibular joint examination Exclusion Criteria: * Active periodontal problems including tooth mobility * active temporomandibular joint dysfunction * Edentulous patients or Insufficient teeth to support MAD * patients with severe unstable systemic diseases or suffering from psychiatric disorders * Enlarged palatine tonsils (Friedman grade IV tonsils)

Treatments Being Tested

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.

Locations (1)

Beijing Jishuitan Hospetal

Beijing, Beijing Municipality, China