NCT07845331尚未招募不适用
Evaluation of the Effectiveness of a New Mandibular Advancement Device (BioMAD) in the Treatment of Obstructive Sleep Apnea
University of Lausanne Hospitals0 个研究点目标入组 20 人开始时间: 2026年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea.
详细描述
The severity of OSA and associated symptoms will be assessed with the patients' usual mandibular devive (MAD), with no treatment (after a wash-out period), and with the new treatment (BioMAD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult (≥ 18 years) with diagnosis of obstructive sleep apnea (AHI ≥ 5/h).
- •Current use of a ResMed or SomnoMed MAD for at least 3 months with reported adherence ≥ 4 hours/night.
- •Ability and willingness to stop using the current MAD for a two-week wash-out period.
- •Agrees to be informed on incidental findings
- •Capable of giving informed consent.
排除标准
- •Predominant central sleep apnea.
- •Known temporo-mandibular joint disorders or significant dental conditions that preclude MAD use.
- •Recent dental surgery (< 1 month) or planned during the investigation.
- •Known pregnancy, breastfeeding or planning pregnancy during the study;
- •Professional drivers or occupations requiring constant vigilance (due to risk of increased sleepiness during wash-out).
- •Participation in another interventional trial or use of medications affecting sleep (sedative/hypnotic agents, opioids, muscle relaxants).
研究组 & 干预措施
single arm
Active Comparator
The patients will be recorded with their usual MAD Device, after a 2 week wash out period and under the new BioMAD device
干预措施: BioMAD (Device)
结局指标
主要结局
Apnea Hypopnea Index
时间窗: Baseline, Day 15, Day 30
Number of apneas and hypopneas per hour of sleep measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD.
次要结局
- The hypoxic burden(Baseline, Day 15, Day 30)
- Sleep efficiency and EEG-based sleep microstructure metrics(Baseline, Day 15, Day 30)
- Subjective daytime sleepiness(Baseline, Day 15, Day 30)
- Patients reported outcome measures (PROMS)(Baseline, Day 15, Day 30)
研究者
Raphael Heinzer
Associate Professor
University of Lausanne Hospitals
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