The Social Gradient of Urban Noise Pollution and Its Effect on Pediatric and Adult Health

NCT04822155 | Withdrawn

• 1 other identifier: 833334
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators pilot test an intervention to understand the spatial-temporal distribution of aggregated environmental noise exposure in Philadelphia and its impact on health.

Conditions

Noise Exposure; Environmental Exposure; Health Behavior

Outcome Measures

Primary Outcomes (3)

• Environmental noise measurement of 24 Philadelphia neighborhoods using outdoor remote monitoring via International Electrotechnical Commission (IEC)

  Environmental noise will be directly measured using outdoor remote monitoring via International Electrotechnical Commission (IEC) Class I portable sound level meter systems, which will allow for collection of comprehensive measurements (i.e. every second) over space and time. Noise will be measured for 30 days each at 24 sites, 8 each in low, medium, and high socioeconomic neighborhoods.

  30 days

• Measures of feasibility

  Feasibility will be measured by the amount of usable remote biometric data collected.

  14 days

• Measures of acceptability

  To measure acceptability, qualitative interviews will be conducted to provide insight on participants' experience with Actigraphy devices and sound devices in the home.

  14 days

Secondary Outcomes (7)

• Sleep duration using an Actigraphy device (adults and pediatric)

  14 days

• Sleep quality using an Actigraphy device (adults and pediatric)

  14 days

• Cardiovascular health (adults only)

  14 days

• Neurobehavioral measures (pediatric): BRIEF-II

  14 days

• Neurobehavioral measures (pediatric): CBCL

  14 days

Study Arms (2)

Children

Children between 11-17 years of age will be asked to participate in a home visit, where they respond to questions about certain actions or behaviors that affect their physical, emotional, or mental well-being (BRIEF-II and CBCL questionnaires). The child will also be asked to wear an actigraphy device on their wrist for 14 days while he/she sleeps to track their sleep quality.

Adults

Adults, 18 years and older will be asked to participate in a home visit, where they respond to questions about certain actions or behaviors that affect your physical, emotional, or mental well-being (BRIEF-A and ABCL questionnaires). The adult will also be asked to wear an actigraphy device on their wrist for 14 days while he/she sleeps to track their sleep quality. Additionally, the adult will need to take their blood pressure 3 times per day for 14 days and record measurements.

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our population includes adult (18 years and older) and adolescent (11-17 years) subjects living in target Philadelphia neighborhoods determined by noise profiles (AIM 1).

You may qualify if:

• Residents living within 0.25 miles of the location of an external sound device
• Adults 18 years and older
• Children between 11-17 years of age
• Able to understand and respond to an oral interview in English

You may not qualify if:

• Unwilling to wear an Actigraphy device
• Adults unwilling to take blood pressure

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 30, 2021
• Study Start: March 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12