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EMBED: The Effect of ABPM on Sleep Disturbance

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03866226
Collaborator
(none)
564
Enrollment
1
Location
32.8
Anticipated Duration (Months)
17.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    564 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Effect of Ambulatory Blood Pressure Monitoring on Sleep Disturbance
    Actual Study Start Date :
    Mar 10, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Sleep questionnaire score will be used to evaluate the alteration of sleep [about 2 days]

      Sleep questionnaire score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    XiaoHong PAN, PI, Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT03866226
    Other Study ID Numbers:
    • I2017001235
    First Posted:
    Mar 7, 2019
    Last Update Posted:
    Oct 27, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by XiaoHong PAN, PI, Second Affiliated Hospital, School of Medicine, Zhejiang University
    ambulatory blood pressure monitoring
    sleep
    Additional relevant MeSH terms:
    Dyssomnias
    Parasomnias

    Study Results

    No Results Posted as of Oct 27, 2020