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

NCT06424405 | Recruiting DMC

• 1 other identifier: BeijingJH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.The efficacy of MAD therapy after each titration procedure.
2. 2.The titration time efficiency and the improvement of subjective symptoms after each titration procedure.

Conditions

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Keywords

Obstructive sleep apnea hypopnea syndrome; Sleep monitoring; contactless sensors; Mandibular advancement device; therapeutic outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• Epworth sleepiness score(ESS)

  ESS will be determined at baseline and the end of titration procedures (up to 60 days).

• Snore Scale(SS）

  SS will be determined at baseline and the end of titration procedures (up to 60 days).

Study Arms (2)

objective titration procedure

EXPERIMENTAL

Objective titration procedure will be based on the objective diagnosis and treatment indicator AHI（Apnea-hypopnea index）which will be provided by RISMS (Remotely intelligent sleep monitoring system). SC-500TM is a comfortable contactless under-mattress sleep monitor, as a main component of the RISMS will be given to patients to collect the sleep data every night at home setting. The sleep report will be generated automatically every day providing the value of AHI and uploaded to the clinicians in real-time. The clinicians will contact the patients by phone every 3-7 days and instruct them remotely to adjust the MAD to increase the mandibular advancement by 0.25-1mm each time, according to AHI together with the self-reported evolution of symptoms. The patients will adapt this new mandibular advancement for 3-7 days and the clinicians will contact them again for further adjustment until a significant improvement of AHI and resolution of symptoms occurs.

Procedure: titration procedure for MAD treatment

subjective titration procedure

ACTIVE COMPARATOR

The subjective titration procedure in this study will be based on self-reported evolution of symptoms and physical limits of the OSAHS patients. Patients will be recalled to the hospital every 1-2 weeks and will be asked about the subjective changes such as snoring, daytime sleepiness，ache of tooth, temporomandibular pain and so on. Then, the clinicians will adjust the MAD to increase degree of mandibular advancement by 0.5-1mm each time. The patients will adapt this new mandibular advancement for 1-2 weeks and have to come back to hospital for further adjustment until an improvement or a resolution of symptoms occurs, or until the patients could not tolerate any further advancement.

Procedure: titration procedure for MAD treatment

Interventions

titration procedure for MAD treatment PROCEDURE

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

objective titration procedure; subjective titration procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OSAHS patients with AHI≥15
• ≤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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan Hospetal

Beijing, Beijing Municipality, 100035, China

RECRUITING

Study Officials

• Si S Chen, doctor

  Beijing Jishuitan Hospital

  STUDY CHAIR

Central Study Contacts

Huijia HJ Lei, doctor

CONTACT

8601058516688; leihuijia2006@126.com

Yanwei YW Lv, doctor

CONTACT

8658517106; xiaohan_007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 22, 2024
• Study Start: April 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)