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

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424405
• Other study ID #: BeijingJH
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Beijing Jishuitan Hospital
• Contact: Huijia HJ Lei, doctor
• Phone: 8601058516688
• Email: leihuijia2006[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Country	Name	City	State
China	Beijing Jishuitan Hospetal	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of MAD therapy	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.	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.
Secondary	titration time efficiency	The titration time efficiency is the percentage of saved time over the prescribed time.	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.
Secondary	Epworth sleepiness score(ESS)	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.	ESS will be determined at baseline and the end of titration procedures (up to 60 days).
Secondary	Snore Scale(SS)	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.	SS will be determined at baseline and the end of titration procedures (up to 60 days).