The Effect of ABPM on Sleep Disturbance

Overview

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.

Full Title of Study: “The Effect of Ambulatory Blood Pressure Monitoring on Sleep Disturbance”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: August 31, 2022

Detailed Description

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.

Clinical Trial Outcome Measures

Primary Measures

  • Sleep questionnaire score will be used to evaluate the alteration of sleep
    • Time Frame: about 2 days
    • Sleep questionnaire score

Participating in This Clinical Trial

Inclusion Criteria

1. Signed written informed consent 2. Age 18-80 years 3. Capable of understanding the test and cooperating with the questionnaire. Exclusion Criteria:

1. History of psychosis, including schizophrenia, bipolar disorder, depression, anxiety, obsessive-compulsive disorder, phobia, somatoform disorder, stress-related disorders 2. History of insomnia, currently with medication 3. History of obstructive sleep apnea (OSA) 4. History of other sleep disorders, including narcolepsy/hypersomnias, circadian rhythm sleep disorder, parasomnias, sleep-related dyskinesia 5. History of heart failure, that is New York heart association (NYHA) Class Ⅲ-Ⅳ 6. History of atrial fibrillation and frequent atrial or ventricular extrasystoles 7. Ongoing substance or alcohol abuse 8. Currently receiving sedative hypnotic medication within 1 week 9. Pregnant women 10. Ongoing involvement in night-shift work (22:00-6:00) within 1 week 11. Ongoing need of care of families at home that wake during the night within 1 week 12. Incomprehensible or unwilling to fill in informed consent or questionnaire

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • Principal Investigator: XiaoHong PAN, PI – Second Affiliated Hospital, School of Medicine, Zhejiang University

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