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OpenTrials
Completed

NCT Number: NCT05394376

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)

    Time frame: Time of reading up to 90 minutes

    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

  2. Difference between first diastolic BP and average of 3 diastolic BPs from measurements (mmHg)

    Time frame: Time of reading up to 90 minutes

    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

  3. Systolic and Diastolic Differences in blood pressure measurement (mmHg)

    Time frame: Time of reading up to 90 minutes

    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)

Secondary outcomes

  1. Difference in blood pressure measurement based on blood pressure level

    Time frame: Time of reading up to 90 minutes

    To determine the difference in blood pressure measurements based on blood pressure level (SBP ≥130 mmHg vs. SBP <130 mmHg)

  2. Difference in blood pressure measurement based on age

    Time frame: Time of measurement up to 90 minutes

    To determine the blood pressure difference based on age (≥ 60 years vs. <60 years).

  3. Difference in blood pressure measurement based on regular healthcare visits

    Time frame: Time of measurement up to 90 minutes

    To determine the blood pressure difference based on regular healthcare visits (>1 year vs. ≤ 1 year)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Vital Strategies

Registry information

Official study title

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

Acronym: DECIBEL(S)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 27, 2022
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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