Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Concentration of neurofilament light chain
研究概览
简要总结
The goal of this observational study is to investigate biomarkers and neurocognitive markers of neurodegenerative processes in obstructive sleep apnea patients.
The main questions the study aims to answer are:
- Does neurodegeneration assessed by neurobiological markers and neurocognitive test performance exists in obstructive sleep apnea?
- Are these neurodegenerative markers are associated with the adherence to clinical prescribed positive airway pressure therapy?
Newly diagnosed patients with obstructive sleep apnea will be observed during the use of clinical prescribed positive pressure therapy. Different study related investigations take place before and six months after treatment start.
Researchers will compare after six months the group of adherent treatment participants with the non-adherent treatment participants group to investigate if differences in the observed neurobiological or neurocognitive parameters exist.
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
- •newly diagnosed obstructive sleep apnea
- •clinical indication for start of positive airwas pressure therapy
- •Age older than 18 years
排除标准
- •neurodegenerative disease
- •Multiple sclerosis
- •Stroke within last 3 months
- •Brain injury within last 3 months
- •MoCA < 21 points
- •higher degree chonic kidney disease (lower than 30 mL/min)
- •regular use of sleep pills (e.g. Zopiclon, Mirtazapin, Daridorexant)
结局指标
主要结局
Concentration of neurofilament light chain
时间窗: From enrollment to the follow up time point after 6 months of treatment
longitudinal analysis
次要结局
- Subjective sleep parameters measured by symptoms questionnaires (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index)(From enrollment to the follow up time point after 6 months of treatment)
- Concentration of Glial fibrillary acidic protein(From enrollment to the follow up time point after 6 months of treatment)
- Objective sleep parameters measured by polysomnography or equivalent measuremt methods(From enrollment to the follow up time point after 6 months of treatment)
- Concentration of Neurofilament light chain(From enrollment to the follow up time point after 6 months of treatment, in between the groups)
- Cognitive performance measured by SDMT, MoCA(From enrollment to the follow up time point after 6 months of treatment)
研究者
Tony Sehr
Principal Investigator
Technische Universität Dresden