A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
- Sponsor
- Beijing Jishuitan Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- efficacy of MAD therapy
- Status
- Recruiting
- Last Updated
- last year
Overview
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:
- The efficacy of MAD therapy after each titration procedure.
- 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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
efficacy of MAD therapy
Time Frame: The parameter of AHI will be recorded at baseline before the titration and the end of the titration procedures (up to 60 days) using the same PSG device to diagnose OSAHS.
The efficacy of MAD therapy is in terms of AHI (Apnea-hypopnea index) reduction compared to baseline, as well as the number of responders defined as patients with a reduction in AHI of 50% or more compared to baseline, and/or a follow-up AHI of 10 events/hour or less.
Secondary Outcomes
- titration time efficiency(The prescribed time is 60 days. The actual titration time is the time taken from the start to the end of the titration procedures (up to 60 days). The saved time is 60 days minus actual titration day.)
- Snore Scale(SS）(SS will be determined at baseline and the end of titration procedures (up to 60 days).)
- Epworth sleepiness score(ESS)(ESS will be determined at baseline and the end of titration procedures (up to 60 days).)