NCT06089161招募中不适用
Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Proportion of participants adherence to OSA treatment
研究概览
简要总结
The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported race/ethnicity as African American, African, Caribbean or black
- •Ages 60-85 years
- •accessible by phone
- •OSA diagnosis
- •consent, including permission to release medical data
排除标准
- •progressive illnesses in which disability or death is expected within 1 year
- •impaired cognitive/ functional ability precluding participation
- •intention to move within the year
- •and a family member currently enrolled.
结局指标
主要结局
Proportion of participants adherence to OSA treatment
时间窗: Up to 6 months
The proportion of participants who answer yes (meaning a participant acknowledges an average of more than 4 hours of continuous positive airway pressure use) or no (meaning a participant acknowledges an average of less than 4 hours of continuous positive airway pressure use).
次要结局
- Change in Cardiometabolic Biomarkers as measured in grams per deciliter(Baseline and 6 months)
- Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.(Baseline and 6 months)
- Change in Cardiometabolic Biomarkers Measured in microgram(Baseline and 6 months)
- Change in Vascular Markers(Baseline and 6 months)
- Change in Cardiometabolic Biomarkers measured in mmol/mol(Baseline and 6 months)
- Change in Molecular Biomarkers(Baseline and 6 months)
- Change in Cardiometabolic Biomarkers- platelet count(Baseline and 6 months)
- Change in Sleep Awakening measured by Fitbit(Baseline, 2 months)
- Change in Cardiometabolic Biomarkers as measured per microliter of Blood.(Baseline and 6 months)
- Change in Cardiometabolic Biomarkers as measured milligrams per liter(Baseline and 6 months)
- Change in Executive Function measured by Dimensional Change Card Sort Test(Baseline, 6 months)
- Change in Health-related quality of life(Baseline, 2 months, 6 months)
- Change in Cardiometabolic Biomarkers measured in mg/dl(Baseline and 6 months)
- Change in NIH Toolbox -Oral Reading Recognition Test(Baseline, 6 months)
- Change in Episodic memory measured by Picture Sequence Memory Test(Baseline, 6 months)
- Change in Processing Speed measured by Patten Comparison Processing Speed Test(Baseline, 6 months)
- Changes in number of minutes as measured by FitBit Sleep Stages(Baseline, 2 months, 6 months)
- Change in the number of floors climbed measured by Fitbit(Baseline, 2 months)
- Change in Cardiometabolic Biomarkers Measured picograms per milliliter(Baseline and 6 months)
- Change in NIH Toolbox Picture Vocabulary Test(Baseline, 6 months)
- Change in NIH Toolbox- Flanker Inhibitory Control and Attention(Baseline, 6 months)
- Change in Working Memory measured by List Sorting Task(Baseline, 6 months)
- Change in Working Memory measured by Number Span Subset(Baseline, 6 months)
- Change in Daytime functioning(Baseline, 2 months, 6 months)
- Changes in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance(Baseline, 2 months, 6 months)
- Changes in Sleep quality measured by Sleep Score(Baseline, 2 months, 6 months)
- Change in Cardiometabolic Biomarkers as measured in percentage(Baseline and 6 months)
- Change in number of calories burned measured by FitBit(Baseline, 2 months, 6 months)
- Change in NIH Toolbox- Auditory Verbal Learning Test(Baseline, 6 months)
- Change in distance traveled measured in Miles by Fitbit(Baseline, 2 months)
- Change in number of steps taken measured by Fitbit(Baseline, 2 months)
研究者
Girardin Jean-Louis
Distinguished Professor
University of Miami
研究点 (2)
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