Clinical trial NCT03866226: The Effect of ABPM on Sleep Disturbance
Official title: The Effect of Ambulatory Blood Pressure Monitoring on Sleep Disturbance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure Monitoring, Ambulatory
Keywords: ambulatory blood pressure monitoring
sleep
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who undergo ABPM in the Second Affiliated Hospital of Zhejiang University School of Medicine

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep questionnaire score will be used to evaluate the alteration of sleep
timeFrame: about 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
citation: 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.