The Effect of ABPM 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.

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Key information

Conditions

Blood Pressure Monitoring, Ambulatory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed written informed consent
Age 18-80 years
Capable of understanding the test and cooperating with the questionnaire.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Sleep questionnaire score will be used to evaluate the alteration of sleep

Time frame: about 2 days

Sleep questionnaire score

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

The Effect of Ambulatory Blood Pressure Monitoring on Sleep Disturbance

Acronym: EMBED

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Mar 7, 2019
Registry last updated: Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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