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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Level of noise and environment (public vs private) while taking blood pressure measurement

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tammy Brady, MD, PhD; Phone Number: 443-287-8968; Email: tbrady8@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2; 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; 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.
Other: Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2; 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; 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.
Other: Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2; 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; 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.
Other: Inside public quiet, inside public loud, inside private quiet1, inside private quiet2; 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; 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.
Other: Inside public quiet, inside private quiet1, inside public loud, inside private quiet2; 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; 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.
Other: Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Vital Strategies
• Investigators: Principal Investigator: Tammy Brady, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB00322730

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No