The Effect of ABPM on Sleep Disturbance

Completed

• Conditions: Blood Pressure Monitoring, Ambulatory

• Registration Number: NCT03866226
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Study Start: 2019-03-10
• Primary Completion: 2022-08-31
• Study Completion: 2022-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-05
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 564

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep questionnaire score will be used to evaluate the alteration of sleep	about 2 days	Sleep questionnaire score

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China