A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients
NCT ID: NCT06424405
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-25
2025-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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objective titration procedure
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.
titration procedure for MAD treatment
The OSAHS patients referred for MAD treatment will experience either the objective titration procedure or the subjective titration procedure.
subjective titration procedure
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.
titration procedure for MAD treatment
The OSAHS patients referred for MAD treatment will experience either the objective titration procedure or the subjective titration procedure.
Interventions
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titration procedure for MAD treatment
The OSAHS patients referred for MAD treatment will experience either the objective titration procedure or the subjective titration procedure.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
70 Years
ALL
No
Sponsors
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Beijing Jishuitan Hospital
OTHER
Responsible Party
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Principal Investigators
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Si S Chen, doctor
Role: STUDY_CHAIR
Beijing Jishuitan Hospital
Locations
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Beijing Jishuitan Hospetal
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BeijingJH
Identifier Type: -
Identifier Source: org_study_id
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