Self-Reported vs Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a treatment option for sleep-disordered breathing (SDB).
The purpose of this study is to compare active measurement of MRA compliance with patient's self-report.
详细描述
Background Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a conservative treatment option for sleep-disordered breathing (SDB).
Up to this date, no objective method is available to measure compliance during oral appliance treatment for SDB.
As with CPAP in the early years, the sleep apnea community nowadays has a strong interest in the objective measurement of oral appliance use and adherence. Subjective measures and self-report commonly result in overestimation of compliance.
Methods We will perform a 12-week clinical trial comparing active/objective measurement of compliance with subjective self-reported usage.
We will enroll 50 patients with an established diagnosis of SDB that received treatment with a titratable, duobloc MRA (RespiDent Butterfly® MRA, RespiDent, Nijlen, Belgium).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of sleep-disordered breathing
- •started treatment with oral appliances, such as mandibular repositioning appliances
排除标准
- •dental exclusion criteria for MRA
- •medical contra-indications for MRA
研究者
Ethisch Comité UZ Antwerpen
Ethical Comité Antwerp
University Hospital, Antwerp