The Effect of Ambulatory Blood Pressure Monitoring on Sleep Disturbance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Sleep questionnaire score will be used to evaluate the alteration of sleep
研究概览
简要总结
Ambulatory blood pressure monitoring (ABPM) is an ideal tool for the diagnosis and evaluation of hypertension.However, ABPM frequently measures the tightening feeling and buzzing sound of the blood pressure cuff during nighttime, which can cause the patient to wake up easily during sleep, which will affect the sleep of the patient. Moreover, improper awakening of the patient from sleep can significantly increase the patient's blood pressure and affect the accuracy of ABPM monitoring. The Effect of ABPM on Sleep Disturbance (EMBED) study is designed to examine whether ABPM affects sleep, as well as the relationship and influencing factors of sleep and ABPM results, and screening for people who are susceptible to ABPM testing.
详细描述
Participants who accept ABPM in the Second Affiliated Hospital of Zhejiang University School of Medicine, will be recruited for EMBED enrollment. Participants will be asked to provide basic background information and to fill out the STOP-BANG evaluation form. Anxiety, depression, insomnia, sleep questionnaire and pain assessment scale for cuff inflation are used to assess characteristics of participants and their sleep quality. Before ABPM starts, office blood pressure of participants will be measured. Participants will undergo ABPM under standardized guidance. At the end of ABPM, participants will be asked to fill in sleep questionnaire and pain assessment scale for cuff inflation again. EMBED proposes to study whether ABPM affects sleep, as well as the relationship and influencing factors of sleep and ABPM results, and screening for people who are susceptible to ABPM testing. A better understanding of interaction between ABPM and sleep will help us further evaluate the accuracy of ABPM and more precisely control diurnal hypertension in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent
- •Age 18-80 years
- •Capable of understanding the test and cooperating with the questionnaire.
排除标准
- •History of psychosis, including schizophrenia, bipolar disorder, depression, anxiety, obsessive-compulsive disorder, phobia, somatoform disorder, stress-related disorders
- •History of insomnia, currently with medication
- •History of obstructive sleep apnea (OSA)
- •History of other sleep disorders, including narcolepsy/hypersomnias, circadian rhythm sleep disorder, parasomnias, sleep-related dyskinesia
- •History of heart failure, that is New York heart association (NYHA) Class Ⅲ-Ⅳ
- •History of atrial fibrillation and frequent atrial or ventricular extrasystoles
- •Ongoing substance or alcohol abuse
- •Currently receiving sedative hypnotic medication within 1 week
- •Pregnant women
- •Ongoing involvement in night-shift work (22:00-6:00) within 1 week
- •Ongoing need of care of families at home that wake during the night within 1 week
- •Incomprehensible or unwilling to fill in informed consent or questionnaire
结局指标
主要结局
Sleep questionnaire score will be used to evaluate the alteration of sleep
时间窗: about 2 days
Sleep questionnaire score
次要结局
未报告次要终点
研究者
XiaoHong PAN
PI
Second Affiliated Hospital, School of Medicine, Zhejiang University