A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- efficacy of MAD therapy
研究概览
简要总结
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:
- The efficacy of MAD therapy after each titration procedure.
- The titration time efficiency and the improvement of subjective symptoms after each titration procedure.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
efficacy of MAD therapy
时间窗: 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.
次要结局
- 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.)
- Snore Scale(SS）(SS will be determined at baseline and the end of titration procedures (up to 60 days).)
- Epworth sleepiness score(ESS)(ESS will be determined at baseline and the end of titration procedures (up to 60 days).)