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

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

• Registration Number: NCT06424405
• Lead Sponsor: Beijing Jishuitan Hospital

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.

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 Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-25
• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
efficacy of MAD therapy	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 Outcome Measures

Name	Time	Method
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.	The titration time efficiency is the percentage of saved time over the prescribed time.
Snore Scale(SS）	SS will be determined at baseline and the end of titration procedures (up to 60 days).	SS （Snore Scale） is measured by A 10-point visual analogue scale (VAS) to assess the severity of snoring, with the VAS ranging from 0, representing no snoring, to 10, causing the bed partner to leave the room or sleep separately. Lower scores mean a better treatment outcome.
Epworth sleepiness score(ESS)	ESS will be determined at baseline and the end of titration procedures (up to 60 days).	The ESS (Epworth Sleepiness Scale) is a self-administered questionnaire that evaluates subjective daytime sleepiness in quotidian situations. The score ranges from 0 to 24 and is usually elevated in sleep apnea patients, indicating a propensity to fall asleep. The score 0 means no sleepiness at daytime, and the score 24 means serious sleepiness. Lower scores mean a better treatment outcome.

Trial Locations

Locations (1)

Beijing Jishuitan Hospetal; 🇨🇳 Beijing, Beijing, China