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临床试验/NCT06463002
NCT06463002尚未招募不适用

Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年7月最近更新:
适应症

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

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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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