Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Average daily use (hours)
研究概览
简要总结
This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance monitoring group (control group). A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.
详细描述
The design of this study is a randomized controlled trial. Total 40 participants are randomly divided into 2 groups: objective compliance monitoring (n=20) and subjective compliance monitoring (n=20). Both groups wear the same MAD (commercial name: SomnoDent Flex with DentiTrac). They visit Seol National University Hospital at 1, 3, and 6 month after the initiation of MAD. A research coordinator acquires data by downloading from the MAD or by asking the patients, and then transfer the information to the physician. If the patient belongs to objective compliance group, data from the MAD will be transferred to the physician. But if the patient belongs to subjective compliance group, data acquired by asking patients will be transferred to the physician. A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.The primary aims is to examine the effectiveness of SomnoDent Flex with DentiTrac, in terms of compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •obstructive sleep apnea patients without a history of soft palate surgery and moderate to severe periodontal disease.
排除标准
- •central sleep apnea
- •active mandibular disease
- •tooth grinding
- •moderate to severe periodontal disease
研究组 & 干预措施
MAD for objective compliance
MAD for objective compliance group wears the same SomnoDent Flex with DentiTrac to subjective group, but they are subjected to be prescribed based on the objective compliance data, which are acquired from data recorded within SomnoDent Flex with DentiTrac.
干预措施: SomnoDent Flex with DentiTrac (Device)
MAD for subjective compliance
MAD for subjective compliance group wears the same SomnoDent Flex with DentiTrac to objective group, but they are subjected to be prescribed based on the subjective compliance data, which are acquired from patient's explanation. Compliance (average daily time,
干预措施: SomnoDent Flex with DentiTrac (Device)
结局指标
主要结局
Average daily use (hours)
时间窗: one month
The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month
次要结局
- Days used for ≥ 15 min(one month)
- Days used for ≥ 4 hrs(one month)
研究者
Hyun-Woo Shin
Professor
Seoul National University Hospital