Blood Pressure Monitoring, AmbulatoryEMBEDNCT03866226
The Effect of ABPM on Sleep Disturbance
An observational study of Blood Pressure Monitoring, Ambulatory, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Monitoring, Ambulatory
- How many people
- 564 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2019to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who undergo ABPM in the Second Affiliated Hospital of Zhejiang University School of Medicine
Who may be able to join
- Signed written informed consent
- Age 18-80 years
- Capable of understanding the test and cooperating with the questionnaire.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: The Effect of Ambulatory Blood Pressure Monitoring 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.
Read the 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.
- Conditions
- Blood Pressure Monitoring, Ambulatory
- Keywords
- ambulatory blood pressure monitoring, sleep
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep questionnaire score will be used to evaluate the alteration of sleep
Sleep questionnaire score
Measured: about 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start10 Mar 2019
- Primary completion31 Aug 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure Monitoring, AmbulatoryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoHong PAN, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866226
- Sponsor's protocol ID
- I2017001235
- Acronym
- EMBED
- Status last verified
- Nov 2022
- First submitted
- 5 Mar 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34888099
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ambulatory Blood Pressure Monitoring on Sleep Disturbance
- ClinicalTrials.gov ID
- NCT03866226
- Acronym / sponsor ID
- EMBED / I2017001235
- Conditions
- Blood Pressure Monitoring, Ambulatory
- Keywords
- ambulatory blood pressure monitoring, sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who undergo ABPM in the Second Affiliated Hospital of Zhejiang University School of Medicine
Key inclusion criteria (3 listed)
- Signed written informed consent
- Age 18-80 years
- Capable of understanding the test and cooperating with the questionnaire.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep questionnaire score will be used to evaluate the alteration of sleep
Time frame: about 2 days
Sleep questionnaire score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 34888099Qian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure Monitoring, Ambulatory, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep questionnaire score will be used to evaluate the alteration of sleep (time frame: about 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.