Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 24-hour mean systolic blood pressure
研究概览
简要总结
To compare the blood pressure control and cognitive responses of three groups of patients: those diagnosed with Obstructive Sleep Apnea (OSA) and treated with Continuous Positive Airway Pressure (CPAP) for at least six months, those diagnosed with OSA but not treated, and those without OSA.
详细描述
This study is designed as an observational, cross-sectional investigation at the National University Hospital and Alexandra Hospital. The research aims to enroll 50 eligible patients in each of the three groups (OSA treated, OSA untreated, and non-OSA, totaling 150 participants). The recruited participants will undergo ambulatory blood pressure monitoring (ABPM) and the Montreal Cognitive Assessment (MoCA). ABPM is a widely used, noninvasive method to determine patients' blood pressure control. MoCA is a widely used screening tool designed to assess cognitive function and detect mild cognitive impairment or early signs of dementia. The MoCA evaluates various cognitive domains, including attention, memory, language, visuospatial abilities, executive functions, and orientation. It consists of a series of tasks and questions that assess different aspects of cognitive functioning, such as drawing specific shapes, recalling words or numbers, and performing simple calculations. A trained healthcare professional will administer the digital version of the MoCA, which usually takes less than 30 minutes to complete. The MoCA has been validated for use in diverse populations and has shown good sensitivity in detecting mild cognitive impairment. The maximum score on the MoCA is 30. Lower scores may indicate potential cognitive impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known OSA (AHI >/=15 events/ hour, based on sleep study) on CPAP treatment for at least six months (n=50)
- •Known OSA (AHI >/=15 events/ hour, based on sleep study) NOT on CPAP treatment (n=50)
- •Known non-OSA (AHI <15 events/ hour, based on sleep study) (n=50)
排除标准
- •Known-OSA on non-CPAP treatment (e.g., mandibular advancement device, surgery, or hypoglossal nerve stimulation),
- •Heart failure,
- •Atrial fibrillation, or acute coronary syndrome in the prior 3 months
- •Dementia (based on the medical record)
- •Previous stroke
- •Non-English-speaking subjects
- •Pregnant and lactating women
结局指标
主要结局
24-hour mean systolic blood pressure
时间窗: Within 4 weeks after consent (one time)
A 24-hour ambulatory blood pressure monitoring will be performed
Montreal Cognitive Assessment (MoCA)
时间窗: Within 4 weeks after consent (one time)
Montreal Cognitive Assessment scale (0-30). Lower the scale means more severe cognitive impairment
次要结局
- Office systolic blood pressure(Within 4 weeks after consent (one time))
- MoCA score <27 (for those with >10 years of education) and <26 (for those with ≤10 years of education)(Within 4 weeks after consent (one time))
- Montreal Cognitive Assessment (MoCA) <20(Within 4 weeks after consent (one time))
- 24-hour systolic blood pressure <120 mmHg(Within 4 weeks after consent (one time))
- Epworth Sleepiness Scale(Within 4 weeks after consent (one time))
- Nocturnal blood pressure dipping(Within 4 weeks after consent (one time))
- Montreal Cognitive Assessment (MoCA) <27(Within 4 weeks after consent (one time))
- 24-hour systolic blood pressure <130 mmHg(Within 4 weeks after consent (one time))
