The Effect of ABPM on Sleep Disturbance (EMBED)

The Effect of Ambulatory Blood Pressure Monitoring on Sleep Disturbance

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure Monitoring, Ambulatory

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.

• Study Type: Observational
• Enrollment (Actual): 564

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants who undergo ABPM in the Second Affiliated Hospital of Zhejiang University School of Medicine

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep questionnaire score will be used to evaluate the alteration of sleep	Sleep questionnaire score	about 2 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• Qian N, Yang D, Li H, Ding S, Yu X, Fan Q, Yu Z, Ye S, Yu H, Wang Y, Pan X. Considering Psychosocial Factors When Investigating Blood Pressure in Patients with Short Sleep Duration: A Propensity Score Matched Analysis. Int J Hypertens. 2021 Nov 30;2021:7028942. doi: 10.1155/2021/7028942. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2019
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: sleep; ambulatory blood pressure monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: I2017001235

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No