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Determining Change In Blood Pressure Due to Environment and Loudness

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05394376
Acronym
DECIBEL(S)
Enrollment
108
Registered
2022-05-27
Start date
2022-08-09
Completion date
2023-06-01
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

OTHERLevel 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.

Sponsors

Vital Strategies
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)Time of reading up to 90 minutesAbsolute 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
Difference between first diastolic BP and average of 3 diastolic BPs from measurements (mmHg)Time of reading up to 90 minutesAbsolute 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
Systolic and Diastolic Differences in blood pressure measurement (mmHg)Time of reading up to 90 minutesSystolic 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)

Secondary

MeasureTime frameDescription
Difference in blood pressure measurement based on blood pressure levelTime of reading up to 90 minutesTo determine the difference in blood pressure measurements based on blood pressure level (SBP ≥130 mmHg vs. SBP \<130 mmHg)
Difference in blood pressure measurement based on ageTime of measurement up to 90 minutesTo determine the blood pressure difference based on age (≥ 60 years vs. \<60 years).
Difference in blood pressure measurement based on regular healthcare visitsTime of measurement up to 90 minutesTo determine the blood pressure difference based on regular healthcare visits (\>1 year vs. ≤ 1 year)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026