Determining Change In Blood Pressure Due to Environment and Loudness

Hypertension Clinical Trial

— DECIBEL(S)  

Official title:

DECIBEL(S): Determining Change In Blood Pressure Due to Environment and Loudness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394376
• Other study ID #: IRB00322730
• Status: Completed
• Phase: N/A
• Start date: August 9, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the effects of environment and sound on initial and average triplicate screening blood pressure done according to clinical practice guidelines with an automated device.

Standardly obtained blood pressures obtained in a noisy, busy, public space will be higher than attended blood pressures obtained (1) in the same environment but with earplugs to minimize sound and (2) in a quiet, private space without surrounding activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

Exclusion Criteria:

• Hearing loss requiring hearing aids

• Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, A-V shunts.

• Being mentally impaired

• Being pregnant

• Arm circumference exceeding 55 cm.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Vital Strategies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)	Absolute difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg) obtained in: Inside public loud vs. Inside private quiet1; Inside public quiet vs. Inside private quiet1; Inside private quiet1 vs. Inside private quiet2	Time of reading up to 90 minutes
Primary	Difference between first diastolic BP and average of 3 diastolic BPs from measurements (mmHg)	Absolute difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg) obtained with: Inside public loud vs. Inside private quiet1; Inside public quiet vs. Inside private quiet1; Inside private quiet1 vs. Inside private quiet2	Time of reading up to 90 minutes
Primary	Systolic and Diastolic Differences in blood pressure measurement (mmHg)	Systolic and Diastolic Difference of differences between: (Inside private quiet 1 - Inside private quiet 2) and (Inside public loud- Inside private quiet 1); (Inside private quiet1 - Inside private quiet2) and (Inside public quiet - Inside private quiet1)	Time of reading up to 90 minutes
Secondary	Difference in blood pressure measurement based on blood pressure level	To determine the difference in blood pressure measurements based on blood pressure level (SBP =130 mmHg vs. SBP <130 mmHg)	Time of reading up to 90 minutes
Secondary	Difference in blood pressure measurement based on age	To determine the blood pressure difference based on age (= 60 years vs. <60 years).	Time of measurement up to 90 minutes
Secondary	Difference in blood pressure measurement based on regular healthcare visits	To determine the blood pressure difference based on regular healthcare visits (>1 year vs. = 1 year)	Time of measurement up to 90 minutes