The Effect of ABPM on Sleep Disturbance

NCT03866226 | Completed

• 1 other identifier: I2017001235
• Study Type: observational
• Target: 564
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure Monitoring, Ambulatory

Keywords

ambulatory blood pressure monitoring; sleep

Outcome Measures

Primary Outcomes (1)

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

  Sleep questionnaire score

  about 2 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• 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.

  PMID: 34888099 DERIVED

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: March 10, 2019
• Primary Completion: August 31, 2022
• Study Completion: October 30, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

CN (1)