Noise ExposurePOPNCT07554378
A Multilevel Intervention to Prevent Noise Exposure in Farmworkers
A study testing Multilevel Hearing Protection Training in people with Noise Exposure and Hearing Loss, Noise-Induced, run by San Diego State University at 1 site in United States.
Trial summary
This study will test a program to reduce noise exposure and prevent hearing loss among farmworkers. Farmworkers are often exposed to high levels of noise from machinery, which can lead to hearing loss over time. Farms will be randomly assigned to either receive the program or serve as a comparison group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure, Hearing Loss, Noise-Induced, Occupational Exposure
- What is being tested?
- Multilevel Hearing Protection Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Currently employed as a farmworker or supervisor at a participating farm
- Able to provide informed consent
- Able to understand and communicate in Spanish or English
Who cannot join
- Not currently working at a participating farm at the time of recruitment
- Unable or unwilling to wear a personal noise dosimeter during a work shift
- Unable to complete study procedures (e.g., surveys or training)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Diego State University
San Diego, California, 92182
Laura Coco, PhD, AuD, 619-594-3151, lcoco@sdsu.edu
About this study
This study will test a program to reduce noise exposure and prevent hearing loss among farmworkers. Farmworkers are often exposed to high levels of noise from machinery, which can lead to hearing loss over time.
Farms will be randomly assigned to either receive the program or serve as a comparison group. The program includes a short educational video, group discussion, and hands-on training on how to use hearing protection (such as earplugs). Supervisors will also receive brief training on how to support hearing protection use in the workplace.
Read more
Participants will wear a small device (dosimeter) during a work shift to measure noise exposure before the program and again about one month later. Participants will also complete surveys about their knowledge, attitudes, and behaviors related to hearing protection.
A subset of participants will be invited to take part in interviews to understand barriers and facilitators to using hearing protection and implementing the program.
The results of this study will help inform future efforts to improve hearing health and reduce noise exposure in agricultural settings.
Read the detailed description
This study is a cluster randomized controlled trial designed to evaluate a multilevel intervention to reduce occupational noise exposure among farmworkers. Farms will be recruited through community and industry partnerships and randomized in a 1:1 ratio to either the intervention or control condition. Randomization will occur at the farm level to minimize contamination.
The intervention includes both worker- and supervisor-level components. Farmworkers will participate in a training session consisting of a brief educational video on noise exposure and hearing loss, followed by group discussion and hands-on instruction on proper use of hearing protection. Supervisors will receive a brief training focused on identifying noise hazards, promoting hearing protection use, and supporting workplace-level safety practices.
Control sites will not receive the intervention during the study period but will be offered the program after study completion.
Primary outcomes include objective measures of noise exposure assessed using personal dosimeters worn during a full work shift at baseline and approximately one month post-intervention. Dosimeters measure time-weighted average noise exposure, noise dose, and peak sound levels and do not record audio.
Secondary outcomes include farmworker knowledge, attitudes, self-efficacy, and behaviors related to hearing protection, as well as supervisor-level outcomes related to supporting hearing safety. Worksite-level outcomes include availability of hearing protection and presence of noise hazard indicators.
A qualitative component will be conducted with a subset of participants, including farmworkers, supervisors, and external stakeholders, to assess barriers and facilitators to implementation. Interviews will be conducted in participants' preferred language, audio-recorded with consent, and analyzed using established implementation science frameworks.
This study will provide preliminary evidence on the effectiveness and feasibility of a multilevel intervention to reduce noise exposure in agricultural settings and inform future large-scale trials.
- Being tested
- Multilevel Hearing Protection Training
- Keywords
- farmworkers, agriculture, hearing protection, earplugs, occupational noise, hearing conservation, implementation science, Community Health Workers, Workplace intervention, Cluster randomized trial
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel Hearing Protection TrainingBehavioural
Also called Protected Ears Project (PEP)
The intervention is a multilevel behavioral training program designed to reduce occupational noise exposure and promote hearing protection use. Farmworkers participate in a session that includes a brief educational video on noise exposure and hearing loss, group discussion, and hands-on instruction on proper use of hearing protection (e.g., earplugs). Supervisors receive a brief training on identifying noise hazards and supporting hearing protection use among workers. The intervention is intended to be delivered in a group or 1:1 setting by trained research staff or community health workers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Multilevel Intervention Group) | Experimental | Participants at farms assigned to the intervention arm will receive a multilevel intervention that includes a brief educational video on noise exposure and hearing loss, group discussion, and hands-on training on proper use of hearing protection (e.g., earplugs). Supervisors will receive a brief training on identifying noise hazards and supporting hearing protection use among workers. The intervention is delivered in a community or workplace setting by trained study staff or community health workers. Receives: Behavioral: Multilevel Hearing Protection Training |
| Control Arm (Usual Practice) | No intervention | Participants at farms assigned to the control arm will not receive the intervention during the study period. They will complete study assessments, including dosimetry and surveys. The intervention will be offered after study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time-Weighted Average Noise Exposure (dBA)
Objective occupational noise exposure measured using personal dosimeters worn during a full work shift. The primary metric is time-weighted average (TWA) noise exposure in decibels (dBA), calculated using standard NIOSH criteria. Devices do not record audio, only noise levels.
Measured: Baseline and approximately 1 month post-intervention
Change in Noise Dose (%)
Cumulative occupational noise exposure measured as percent noise dose using personal dosimeters worn during a full work shift, calculated using standard NIOSH criteria.
Measured: Baseline and approximately 1 month post-intervention
Secondary outcomes (4)
Change in Hearing Protection Beliefs and Attitudes
Change in self-reported beliefs and attitudes toward hearing protection use, assessed using the 14-item Hearing Protection Beliefs scale. Items are rated on a 4-point Likert scale (1 = disagree to 4 = strongly agree) and summed after reverse-coding negatively worded items. Total scores range from 14 to 56, with higher scores indicating more favorable and accurate beliefs about hearing protection.
Measured: Baseline and approximately 1 month post-intervention
Acceptability of the Hearing Protection Training
Participant-reported acceptability of the training assessed immediately post-training using the Acceptability of Intervention Measure (AIM). The AIM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived acceptability of the training.
Measured: Approximately 1 month post-intervention
Appropriateness of the Hearing Protection Training
Participant-reported appropriateness of the training assessed immediately post-training using the Intervention Appropriateness Measure (IAM). The IAM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived appropriateness of the training.
Measured: Approximately 1 month post-intervention
Feasibility of the Hearing Protection Training
Participant-reported feasibility of the training assessed immediately post-training using the Feasibility of Intervention Measure (FIM). The FIM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived feasibility of the training.
Measured: Approximately 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJul 2032 (estimated)
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 San Diego State UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Farms are randomized in a 1:1 ratio to intervention or control conditions, with randomization occurring at the cluster (farm) level prior to participant recruitment. All eligible participants within each farm receive the condition assigned to that farm. Outcomes are assessed at baseline and approximately one month post-intervention. This cluster randomized, parallel-group design is used to minimize contamination between participants within the same worksite.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554378
- Sponsor's protocol ID
- IRB-26-181
- Other IDs
- 1K23DC022303-01A1
- Acronym
- POP
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data may be shared in the future with qualified researchers upon reasonable request, subject to appropriate data use agreements and protections for participant confidentiality. Due to the small sample size and recruitment within specific worksites, there is a potential risk of re-identification; therefore, data will not be publicly posted and will only be shared in a controlled manner.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Intervention to Prevent Noise Exposure in Farmworkers
- ClinicalTrials.gov ID
- NCT07554378
- Acronym / sponsor ID
- POP / IRB-26-181
- Keywords
- farmworkers, agriculture, hearing protection, earplugs, occupational noise, hearing conservation, implementation science, Community Health Workers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 28 Apr 2026 (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.
This study will test a program to reduce noise exposure and prevent hearing loss among farmworkers. Farmworkers are often exposed to high levels of noise from machinery, which can lead to hearing loss over time.
Farms will be randomly assigned to either receive the program or serve as a comparison group. The program includes a short educational video, group discussion, and hands-on training on how to use hearing protection (such as earplugs). Supervisors will also receive brief training on how to support hearing protection use in the workplace.
Participants will wear a small device (dosimeter) during a work shift to measure noise exposure before the program and again about one month later. Participants will also complete surveys about their knowledge, attitudes, and behaviors related to hearing protection.
A subset of participants will be invited to take part in interviews to understand barriers and facilitators to using hearing protection and implementing the program.
The results of this study will help inform future efforts to improve hearing health and reduce noise exposure in agricultural settings.
Detailed description
This study is a cluster randomized controlled trial designed to evaluate a multilevel intervention to reduce occupational noise exposure among farmworkers. Farms will be recruited through community and industry partnerships and randomized in a 1:1 ratio to either the intervention or control condition. Randomization will occur at the farm level to minimize contamination.
The intervention includes both worker- and supervisor-level components. Farmworkers will participate in a training session consisting of a brief educational video on noise exposure and hearing loss, followed by group discussion and hands-on instruction on proper use of hearing protection. Supervisors will receive a brief training focused on identifying noise hazards, promoting hearing protection use, and supporting workplace-level safety practices.
Control sites will not receive the intervention during the study period but will be offered the program after study completion.
Primary outcomes include objective measures of noise exposure assessed using personal dosimeters worn during a full work shift at baseline and approximately one month post-intervention. Dosimeters measure time-weighted average noise exposure, noise dose, and peak sound levels and do not record audio.
Secondary outcomes include farmworker knowledge, attitudes, self-efficacy, and behaviors related to hearing protection, as well as supervisor-level outcomes related to supporting hearing safety. Worksite-level outcomes include availability of hearing protection and presence of noise hazard indicators.
A qualitative component will be conducted with a subset of participants, including farmworkers, supervisors, and external stakeholders, to assess barriers and facilitators to implementation. Interviews will be conducted in participants' preferred language, audio-recorded with consent, and analyzed using established implementation science frameworks.
This study will provide preliminary evidence on the effectiveness and feasibility of a multilevel intervention to reduce noise exposure in agricultural settings and inform future large-scale trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Farms are randomized in a 1:1 ratio to intervention or control conditions, with randomization occurring at the cluster (farm) level prior to participant recruitment. All eligible participants within each farm receive the condition assigned to that farm. Outcomes are assessed at baseline and approximately one month post-intervention. This cluster randomized, parallel-group design is used to minimize contamination between participants within the same worksite.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Multilevel Intervention Group) | Experimental | Behavioral: Multilevel Hearing Protection TrainingParticipants at farms assigned to the intervention arm will receive a multilevel intervention that includes a brief educational video on noise exposure and hearing loss, group discussion, and hands-on training on proper use of hearing protection (e.g., earplugs). Supervisors will receive a brief training on identifying noise hazards and supporting hearing protection use among workers. The intervention is delivered in a community or workplace setting by trained study staff or community health workers. |
| Control Arm (Usual Practice) | No intervention | –Participants at farms assigned to the control arm will not receive the intervention during the study period. They will complete study assessments, including dosimetry and surveys. The intervention will be offered after study completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Currently employed as a farmworker or supervisor at a participating farm
- Able to provide informed consent
- Able to understand and communicate in Spanish or English
Key exclusion criteria (3 listed)
- Not currently working at a participating farm at the time of recruitment
- Unable or unwilling to wear a personal noise dosimeter during a work shift
- Unable to complete study procedures (e.g., surveys or training)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilevel Hearing Protection TrainingAlso: Protected Ears Project (PEP)The intervention is a multilevel behavioral training program designed to reduce occupational noise exposure and promote hearing protection use. Farmworkers participate in a session that includes a brief educational video on noise exposure and hearing loss, group discussion, and hands-on instruction on proper use of hearing protection (e.g., earplugs). Supervisors receive a brief training on identifying noise hazards and supporting hearing protection use among workers. The intervention is intended to be delivered in a group or 1:1 setting by trained research staff or community health workers. | Behavioural | Intervention Arm (Multilevel Intervention Group) |
Primary outcome
Change in Time-Weighted Average Noise Exposure (dBA)
Time frame: Baseline and approximately 1 month post-intervention
Objective occupational noise exposure measured using personal dosimeters worn during a full work shift. The primary metric is time-weighted average (TWA) noise exposure in decibels (dBA), calculated using standard NIOSH criteria. Devices do not record audio, only noise levels.
Change in Noise Dose (%)
Time frame: Baseline and approximately 1 month post-intervention
Cumulative occupational noise exposure measured as percent noise dose using personal dosimeters worn during a full work shift, calculated using standard NIOSH criteria.
4 secondary outcomes
Change in Hearing Protection Beliefs and Attitudes
Time frame: Baseline and approximately 1 month post-intervention
Acceptability of the Hearing Protection Training
Time frame: Approximately 1 month post-intervention
Appropriateness of the Hearing Protection Training
Time frame: Approximately 1 month post-intervention
Feasibility of the Hearing Protection Training
Time frame: Approximately 1 month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data may be shared in the future with qualified researchers upon reasonable request, subject to appropriate data use agreements and protections for participant confidentiality. Due to the small sample size and recruitment within specific worksites, there is a potential risk of re-identification; therefore, data will not be publicly posted and will only be shared in a controlled manner.
Related trials for Noise Exposure
Active, not recruitingObservational study
Federal Aviation Administration (FAA) National Sleep Study
Noise Exposure
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
RecruitingObservational study
Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia
General Anesthesia, Hemodynamics
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel Hearing Protection Training in people with Noise Exposure and Hearing Loss, Noise-Induced, run by San Diego State University at 1 site in United States.
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 3 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Coco, PhD, AuD (16195943151, lcoco@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time-Weighted Average Noise Exposure (dBA) (time frame: Baseline and approximately 1 month post-intervention). The study lists 2 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 28 Apr 2026.