Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03866226 |
| Other study ID # |
I2017001235 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2019 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
