Determining Change In Blood Pressure Due to Environment and Loudness

NCT05394376 | Completed

• 1 other identifier: IRB00322730
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Difference in blood pressure measurement based on blood pressure level

  Time of reading up to 90 minutes

• Difference in blood pressure measurement based on age

  Time of measurement up to 90 minutes

• Difference in blood pressure measurement based on regular healthcare visits

  Time of measurement up to 90 minutes

Study Arms (6)

Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2

OTHER

The order of noise/environment for participants randomized to this arm will be: Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2

Other: Level of noise and environment (public vs private) while taking blood pressure measurement

Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2

OTHER

The order of noise/environment for participants randomized to this arm will be: Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2

Other: Level of noise and environment (public vs private) while taking blood pressure measurement

Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2

OTHER

The order of noise/environment for participants randomized to this arm will be: Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2

Other: Level of noise and environment (public vs private) while taking blood pressure measurement

Inside public quiet, inside public loud, inside private quiet1, inside private quiet2

OTHER

The order of noise/environment for participants randomized to this arm will be: Inside public quiet, inside public loud, inside private quiet1, inside private quiet2

Other: Level of noise and environment (public vs private) while taking blood pressure measurement

Inside public quiet, inside private quiet1, inside public loud, inside private quiet2

OTHER

The order of noise/environment for participants randomized to this arm will be: Inside public quiet, inside private quiet1, inside public loud, inside private quiet2

Other: Level of noise and environment (public vs private) while taking blood pressure measurement

Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2

OTHER

The order of noise/environment for participants randomized to this arm will be: Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2

Other: Level of noise and environment (public vs private) while taking blood pressure measurement

Interventions

Level of noise and environment (public vs private) while taking blood pressure measurement OTHER

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.

Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2; Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2; Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2; Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2; Inside public quiet, inside private quiet1, inside public loud, inside private quiet2; Inside public quiet, inside public loud, inside private quiet1, inside private quiet2

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Vital Strategies: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Ishigami J, Liu H, Zhao D, Sabit A, Pathiravasan CH, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Effects of Noise and Public Setting on Blood Pressure Readings : A Randomized Crossover Trial. Ann Intern Med. 2025 Feb;178(2):149-156. doi: 10.7326/ANNALS-24-00873. Epub 2025 Jan 28.

  PMID: 39869911 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Environment

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Tammy Brady, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: August 9, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

US (1)