Noise ExposureNCT04822155
The Social Gradient of Urban Noise Pollution and Its Effect on Pediatric and Adult Health
An observational study of Noise Exposure and Environmental Exposure, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Noise Exposure, Environmental Exposure, Health Behavior
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Unwilling to wear an Actigraphy device
- Adults unwilling to take blood pressure
About this study
The investigators pilot test an intervention to understand the spatial-temporal distribution of aggregated environmental noise exposure in Philadelphia and its impact on health.
Read the detailed description
Noise pollution - sound created by human activities considered harmful to health - represents an oft- cited public concern, yet has taken a back seat to other environmental hazards. A limited number of observational studies demonstrate that chronic environmental noise exposure is associated with poor outcomes in adults and children, including cardiovascular disease, poor mental health, impaired sleep, and reduced cognitive performance in children. Further investigation and direct measurement at a community-level is needed to not only better understand the spatial-temporal distribution of aggregated environmental noise exposure and its impact on health, but also to lay the groundwork to develop and evaluate needed noise-reducing interventions.
The broad objective of this pilot proposal is to examine the social gradient of noise at a micro-spatial level in Philadelphia and evaluate its impact on the health of pediatric and adult local residents. Our multi-disciplinary team uniquely combines emerging digital and remote-sensing technologies, and expertise in place- based interventions to achieve the following specific aims: (AIM 1) Document the spatial-temporal distribution of environmental noise exposure across 24 Philadelphia neighborhoods with low, medium, and high socioeconomic status (SES), and (AIM 2) Explore the feasibility of evaluating the relationship between noise exposure and biometric health data - including sleep quality, cardiovascular metrics, and neurobehavioral profiles in pediatric and adult participants.
- Conditions
- Noise Exposure, Environmental Exposure, Health Behavior
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Measures of feasibility
Feasibility will be measured by the amount of usable remote biometric data collected.
Measured: 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.
Measured: 14 days
Secondary outcomes (7)
Sleep duration using an Actigraphy device (adults and pediatric)
Sleep duration will be measured using an Actigraphy device, which helps assess sleep/wake patterns. The Actigraphy is a small, limb-worn activity monitor, typically placed on the wrist or ankle, designed for documenting physical movement associated with applications in psychological monitoring. The device is intended to monitor limb activity associated with movement during sleep.
Measured: 14 days
Sleep quality using an Actigraphy device (adults and pediatric)
Sleep quality will be measured using an Actigraphy device, which helps assess sleep/wake patterns. The Actigraphy is a small, limb-worn activity monitor, typically placed on the wrist or ankle, designed for documenting physical movement associated with applications in psychological monitoring. The device is intended to monitor limb activity associated with movement during sleep.
Measured: 14 days
Cardiovascular health (adults only)
This will be measured using ambulatory blood pressure monitoring three times per day.
Measured: 14 days
Neurobehavioral measures (pediatric): BRIEF-II
This will be measured using the Behavior Rating Inventory of Executive Functions (BRIEF-II). The BRIEF-II evaluates children and adolescents with developmental and acquired neurological conditions. It consists of 63 questions on a Likert-type format with 0 ("Never"), 1 ("Sometimes"), 2 ("Often") that reflect the frequency to which the child being evaluated performs an indicated behavior. Higher scores indicate greater impairment in executive functioning.
Measured: 14 days
Neurobehavioral measures (pediatric): CBCL
The Child Behavioral Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. It consists of 113 questions, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). The time frame for item responses is the past six months. The CBCL is computer scored, in which a trained professional needs to interpret the results.
Measured: 14 days
Neurobehavioral measures (adults): BRIEF-A
This will be measured using the Behavior Rating Inventory of Executive Functions- Adult Version (BRIEF-A). The BRIEF-A captures views of an adult's executive functions or self-regulation in his or her everyday environment. It includes 75 items within nine nonoverlapping scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 0 ("Never"), 1 ("Sometimes"), 2 ("Often"). Higher scores indicate greater impairment in executive functioning.
Measured: 14 days
Neurobehavioral measures (adults): ABCL
The Adult Behavioral Checklist (ABCL) obtains information regarding an adult's adaptive functioning, problems and substance abuse. It consists of 132 questions on eight empirically based scales: Anxiety/Depression, Withdrawal, Somatic Complaints, Thought Problems, Attention Problems, Aggressive Behaviour, Rule Breaking Behaviour, Obsession-Compulsion. Responses are collected using three levels: "not true", "sometime true" and "often true".
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study startMar 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: We did not have enough bandwidth to take on this project due to other project priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822155
- Sponsor's protocol ID
- 833334
- Status last verified
- Dec 2022
- First submitted
- 4 Mar 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Social Gradient of Urban Noise Pollution and Its Effect on Pediatric and Adult Health
- ClinicalTrials.gov ID
- NCT04822155
- Acronym / sponsor ID
- 833334
- Conditions
- Noise Exposure, Environmental Exposure, Health Behavior
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We did not have enough bandwidth to take on this project due to other project priorities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators pilot test an intervention to understand the spatial-temporal distribution of aggregated environmental noise exposure in Philadelphia and its impact on health.
Detailed description
Noise pollution - sound created by human activities considered harmful to health - represents an oft- cited public concern, yet has taken a back seat to other environmental hazards. A limited number of observational studies demonstrate that chronic environmental noise exposure is associated with poor outcomes in adults and children, including cardiovascular disease, poor mental health, impaired sleep, and reduced cognitive performance in children. Further investigation and direct measurement at a community-level is needed to not only better understand the spatial-temporal distribution of aggregated environmental noise exposure and its impact on health, but also to lay the groundwork to develop and evaluate needed noise-reducing interventions.
The broad objective of this pilot proposal is to examine the social gradient of noise at a micro-spatial level in Philadelphia and evaluate its impact on the health of pediatric and adult local residents. Our multi-disciplinary team uniquely combines emerging digital and remote-sensing technologies, and expertise in place- based interventions to achieve the following specific aims: (AIM 1) Document the spatial-temporal distribution of environmental noise exposure across 24 Philadelphia neighborhoods with low, medium, and high socioeconomic status (SES), and (AIM 2) Explore the feasibility of evaluating the relationship between noise exposure and biometric health data - including sleep quality, cardiovascular metrics, and neurobehavioral profiles in pediatric and adult participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling to wear an Actigraphy device
- Adults unwilling to take blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Environmental noise measurement of 24 Philadelphia neighborhoods using outdoor remote monitoring via International Electrotechnical Commission (IEC)
Time frame: 30 days
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.
Measures of feasibility
Time frame: 14 days
Feasibility will be measured by the amount of usable remote biometric data collected.
Measures of acceptability
Time frame: 14 days
To measure acceptability, qualitative interviews will be conducted to provide insight on participants' experience with Actigraphy devices and sound devices in the home.
7 secondary outcomes
Sleep duration using an Actigraphy device (adults and pediatric)
Time frame: 14 days
Sleep quality using an Actigraphy device (adults and pediatric)
Time frame: 14 days
Cardiovascular health (adults only)
Time frame: 14 days
Neurobehavioral measures (pediatric): BRIEF-II
Time frame: 14 days
Neurobehavioral measures (pediatric): CBCL
Time frame: 14 days
Neurobehavioral measures (adults): BRIEF-A
Time frame: 14 days
Neurobehavioral measures (adults): ABCL
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise Exposure and Environmental Exposure, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Environmental noise measurement of 24 Philadelphia neighborhoods using outdoor remote monitoring via International Electrotechnical Commission (IEC) (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.