Open, Prospective Study for the Validation of the Predictive Value of Upper Airway Segmentation and CFD Analysis on Outcome Parameters of the Mandibular Replacement Appliance (MRA) Therapy in Obstructive Sleep Apnea Hypopnea Syndrome OSAHS) Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- changes in mean AHI between visit 1 and visit 2
研究概览
简要总结
In this open prospective study 40 patients who received Mandibular Replacement Appliance (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be included. The patient's sleep will be registered during 2 periods of 2 days: one while the patient does not wear the MRA and, +/- 1 week later, one while the patient wears the MRA. Furthermore, 2 low dose CT scans (one with and one without the MRA device in the mouth) will be taken. These data must allow the investigators to validate the use of functional imaging (segmentation and Computational Fluid Dynamics) as a predictor of the outcome of the MRA therapy in OSAHS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients with documented OSAHS based on the following criteria:
- •AHI >= 5 Complaints of extreme daytime sleepiness with no other explanation and/or 2 or more of the following symptoms:
- •choking or gasping during sleep
- •recurrent awakenings from sleep
- •un-refreshing sleep
- •daytime fatigue
- •impaired concentration
- •Patients who received MRA as treatment for OSAHS
- •AHI >= 5 on at least 1 of the screening nights (patient does not wear MRA device)
- •Male or female patients aged ≥ 18 years
- •Patients with a co-operative attitude
- •Written informed consent obtained
排除标准
- •Pregnant or lactating females or females at risk of pregnancy
- •Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
- •Cancer or any other chronic disease with poor prognosis and/or affecting patient status
- •History of alcohol or drug abuse in the last 2 years
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- •Patients who participate in another clinical study whose investigational plan is judged to interfere or affect any of the measures of this study
结局指标
主要结局
changes in mean AHI between visit 1 and visit 2
时间窗: visit 1 (AHI of 2 nights without MRA) / visit 2 (AHI of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1)
evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients
changes in UA resistance
时间窗: 1 CT scan without MRA (UA resistance without MRA) / 1 CT scan with MRA (UA resistance with MRA)
evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients
次要结局
- changes in mean ESS between visit 1 and visit 2(visit 1 (ESS of 2 nights without MRA) / visit 2 (ESS of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1))
研究者
Wilfried De Backer
Prof. Dr.
University Hospital, Antwerp