Clinical trial NCT06424405: A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients
Official title: A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Keywords: Obstructive sleep apnea hypopnea syndrome
Sleep monitoring
contactless sensors
Mandibular advancement device
therapeutic outcomes
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: efficacy of MAD therapy
timeFrame: 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:
measure: titration time efficiency
timeFrame: 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.
measure: Epworth sleepiness score(ESS)
timeFrame: ESS will be determined at baseline and the end of titration procedures (up to 60 days).
measure: Snore Scale(SS）
timeFrame: SS will be determined at baseline and the end of titration procedures (up to 60 days).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospetal
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Si S Chen, doctor
role: STUDY_CHAIR
References: