Noise-Induced Hearing LossIHHANANCT07534098
Intervention for Hearing Health Among Native Americans
A study testing Talking Circle and Diabetes prevention program & delayed TC in people with Noise-Induced Hearing Loss, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The purpose of the study is to understand the cultural impact on hearing loss among Native American populations who traditionally rely on oral communication. This Native American community based participatory research hearing protection study proposes to implement a culturally relevant Talking Circles intervention to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise-Induced Hearing Loss
- What is being tested?
- Talking Circle and Diabetes prevention program & delayed TC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2027to 30 Apr 2030
- 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
- Indigenous or Native American community member
- Age 18 years and older
- May work in a noisy environment
- Willing to give informed consent to participate in the study
- People without hearing loss and with hearing loss as well
Who cannot join
- Younger than the age of 18
- Non Native American community member
- Unwillingness to provide informed consent to participate in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
John R Lowe, RN, PHD, FAAN contact
United States2 sites
American Indians In Texas at the Spanish Colonial Missions
San Antonio, Texas, 78205
American Indians In Texas at the Spanish Colonial Missions
San Antonio, Texas, 78205
Ramon D. Vasquez, 210-227-4940, Ramondv@aitscm.org
About this study
The purpose of the study is to understand the cultural impact on hearing loss among Native American populations who traditionally rely on oral communication. This Native American community based participatory research hearing protection study proposes to implement a culturally relevant Talking Circles intervention to address hearing health inequities among Native Americans. The goal is to establish a sustainable culturally based Talking Circle (TC) hearing loss prevention program to disseminate messages, thus promote hearing health and improve access to preventive tools within the larger tribal community with high occupational and recreational noise exposure.
TC Participants will:
Read more
- Complete a set of questionnaires (3 total) throughout the study.
- Complete an audiometer hearing test with headphones, and watch one video computer related to hearing and how to protect hearing at the tribal wellness center.
- In 6-months into the trial, participants will be asked to complete the same set of questionnaires from the beginning of the study.
- In 12-months after the baseline surveys and hearing test, participants will be asked to complete the same set of questionnaires that were done at the beginning of the study and complete another hearing test by the computer.
The intervention will include facilitator training for local implementation and a delayed-intervention control to assess knowledge gains and protective behavior changes. Through use of the TC, the participants in the training program can use the support and insight from each other to be trained to establish self-sustaining hearing loss prevention program in the tribal community.
- Conditions
- Noise-Induced Hearing Loss
- Being tested
- Talking Circle, Diabetes prevention program & delayed TC
- Keywords
- Native American, hearing health
- 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.
Talking CircleBehavioural
The TC intervention involves applying a tribal specific theory-based approach. The TCI is based within the Native Reliance theoretical model, which is a cultural identity construct that reflects the holistic worldview, values, beliefs, and behaviors within Native American culture. The community partnership community will assess and validate appropriate tribal language, community needs, and culturally content to be included in the TCI.
Diabetes prevention program & delayed TCBehavioural
The control group participants will receive the video/audio computer program on hearing, hearing loss, and diabetes prevention strategies. Participants will receive the delayed TCI after completing the 12-month follow up.
| Study group | Role | What they receive |
|---|---|---|
| Talking Circle Intervention | Experimental | At baseline, all the participants will complete assessment surveys and hearing tests in their designated community centers. All participants randomized to the experimental group will receive the TCI immediately after baseline assessment as well as the hearing test and computer-based intervention. Each TCI group includes 10 participants who will receive TCI together at a time and day that works the best. Receives: Behavioral: Talking Circle |
| Control group | Other | Participants randomized to the control group will receive the delayed TCI after completing the 12-month follow up. Partcipants will receive the second hearing tests 12-months into the study and receive feedback on their hearing test results in comparison with the previous year's result. The control group will be asked to randomly participate in a focus group at the completion of the study. Receives: Behavioral: Diabetes prevention program & delayed TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy in Use of Hearing Protection
Participants' confidence in their ability to use hearing protection devices correctly will be assessed using a 2-item scale, rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors, including self-efficacy as reflecting procedure knowledge (how to do), that serve as mediators of the use of hearing protection. An example of an item from this scale is, "I am sure I can use my hearing protection, so it works effectively."
Measured: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Benefits of Use of Hearing Protection
Participants' beliefs regarding the positive results of using hearing protection devices will be assessed by using a 3-item scale, which is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors that serve as mediators of the use of hearing protection. One of these factors includes the benefits of use as one of two components reflecting declarative knowledge (factual). A sample item for this scale is "Wearing hearing protection protects me against hearing loss from noise exposure."
Measured: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Barriers to Use of Hearing Protection
Participants' beliefs about the potential negative aspects of hearing protection device use (i.e., inconvenience, discomfort, difficulty using hearing protection devices, and interference with communication) will be assessed using a 6-item scale, which is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors that serve as mediators of the use of hearing protection. One of these factors includes the barriers to use as one of two components reflecting declarative knowledge (factual). A sample item for his scale is, 'Hearing protection keeps me from hearing what I want to hear."
Measured: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Use of Hearing Protections Devices
This 2-item scale will measure participants' frequency of hearing protection device use when exposed to high noise level at two time points (the past three months and one month), with data collected at baseline and at 6 and 12-month posttests. A sample item is " What percent of the time (0-100%) did you actually use ear plugs or muffs in the past three months when you were exposed to loud noise?" As the two scores for the two time points are expected to show a strong correlation, the mean of two scores will be used as the outcome variable.
Measured: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Noise-Induced Hearing LossStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Crossover
- Model description
- A randomized experimental pretest-posttest control group design will be used to test the effectiveness of the intervention. All participants assigned to experimental group will receive the talking circle intervention (TCI) immediately after baseline assessment and hearing test. To assess the mid-term and long-term effects of the intervention, follow-up assessments will be completed at 6-months and 12-months post-intervention with the offer of incremental increased incentives to reduce attrition. The control group will receive the delayed TCI after completing the 12-month follow up. Both groups will receive the second hearing tests at the 12-month mark and receive feedback on their hearing test results in comparison with the previous year's result.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Oi Saeng Hong, PhD, RN, FAAN, FAAOHN, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534098
- Sponsor's protocol ID
- 24-42381
- Other IDs
- 1R01NR021182-01A1
- Acronym
- IHHANA
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lowe J, Liang H, Riggs C, Henson J, Elder T. Community partnership to affect substance abuse among Native American adolescents. Am J Drug Alcohol Abuse. 2012 Sep;38(5):450-5. doi: 10.3109/00952990.2012.694534.
PubMed 22931079Hong O, Ronis DL, Lusk SL, Kee GS. Efficacy of a computer-based hearing test and tailored hearing protection intervention. Int J Behav Med. 2006;13(4):304-14. doi: 10.1207/s15327558ijbm1304_5.
PubMed 17228988Hong O, Chin DL, Ronis DL. Predictors of hearing protection behavior among firefighters in the United States. Int J Behav Med. 2013 Mar;20(1):121-30. doi: 10.1007/s12529-011-9207-0.
PubMed 22161219Hong O, Lusk SL, Ronis DL. Ethnic differences in predictors of hearing protection behavior between Black and White workers. Res Theory Nurs Pract. 2005 Spring;19(1):63-76. doi: 10.1891/rtnp.19.1.63.66339.
PubMed 15989167Lowe J, Wagner E, Hospital M, et al. Utility of the Native-Reliance theoretical framework, model, and questionnaire. Journal of Cultural Diversity. 2019 26(2):61-68.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Hearing Health Among Native Americans
- ClinicalTrials.gov ID
- NCT07534098
- Acronym / sponsor ID
- IHHANA / 24-42381
- Conditions
- Noise-Induced Hearing Loss
- Keywords
- Native American, hearing health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Texas at Austin
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 16 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.
The purpose of the study is to understand the cultural impact on hearing loss among Native American populations who traditionally rely on oral communication. This Native American community based participatory research hearing protection study proposes to implement a culturally relevant Talking Circles intervention to address hearing health inequities among Native Americans. The goal is to establish a sustainable culturally based Talking Circle (TC) hearing loss prevention program to disseminate messages, thus promote hearing health and improve access to preventive tools within the larger tribal community with high occupational and recreational noise exposure.
TC Participants will:
- Complete a set of questionnaires (3 total) throughout the study.
- Complete an audiometer hearing test with headphones, and watch one video computer related to hearing and how to protect hearing at the tribal wellness center.
- In 6-months into the trial, participants will be asked to complete the same set of questionnaires from the beginning of the study.
- In 12-months after the baseline surveys and hearing test, participants will be asked to complete the same set of questionnaires that were done at the beginning of the study and complete another hearing test by the computer.
The intervention will include facilitator training for local implementation and a delayed-intervention control to assess knowledge gains and protective behavior changes. Through use of the TC, the participants in the training program can use the support and insight from each other to be trained to establish self-sustaining hearing loss prevention program in the tribal community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized experimental pretest-posttest control group design will be used to test the effectiveness of the intervention. All participants assigned to experimental group will receive the talking circle intervention (TCI) immediately after baseline assessment and hearing test. To assess the mid-term and long-term effects of the intervention, follow-up assessments will be completed at 6-months and 12-months post-intervention with the offer of incremental increased incentives to reduce attrition. The control group will receive the delayed TCI after completing the 12-month follow up. Both groups will receive the second hearing tests at the 12-month mark and receive feedback on their hearing test results in comparison with the previous year's result.
| Arm | Type | Receives |
|---|---|---|
| Talking Circle Intervention | Experimental | Behavioral: Talking CircleAt baseline, all the participants will complete assessment surveys and hearing tests in their designated community centers. All participants randomized to the experimental group will receive the TCI immediately after baseline assessment as well as the hearing test and computer-based intervention. Each TCI group includes 10 participants who will receive TCI together at a time and day that works the best. |
| Control group | Other | Behavioral: Diabetes prevention program & delayed TCParticipants randomized to the control group will receive the delayed TCI after completing the 12-month follow up. Partcipants will receive the second hearing tests 12-months into the study and receive feedback on their hearing test results in comparison with the previous year's result. The control group will be asked to randomly participate in a focus group at the completion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indigenous or Native American community member
- Age 18 years and older
- May work in a noisy environment
- Willing to give informed consent to participate in the study
- People without hearing loss and with hearing loss as well
Key exclusion criteria (3 listed)
- Younger than the age of 18
- Non Native American community member
- Unwillingness to provide informed consent to participate in the study
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 |
|---|---|---|
| Talking CircleThe TC intervention involves applying a tribal specific theory-based approach. The TCI is based within the Native Reliance theoretical model, which is a cultural identity construct that reflects the holistic worldview, values, beliefs, and behaviors within Native American culture. The community partnership community will assess and validate appropriate tribal language, community needs, and culturally content to be included in the TCI. | Behavioural | Talking Circle Intervention |
| Diabetes prevention program & delayed TCThe control group participants will receive the video/audio computer program on hearing, hearing loss, and diabetes prevention strategies. Participants will receive the delayed TCI after completing the 12-month follow up. | Behavioural | Control group |
Primary outcome
Self-efficacy in Use of Hearing Protection
Time frame: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Participants' confidence in their ability to use hearing protection devices correctly will be assessed using a 2-item scale, rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors, including self-efficacy as reflecting procedure knowledge (how to do), that serve as mediators of the use of hearing protection. An example of an item from this scale is, "I am sure I can use my hearing protection, so it works effectively."
Benefits of Use of Hearing Protection
Time frame: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Participants' beliefs regarding the positive results of using hearing protection devices will be assessed by using a 3-item scale, which is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors that serve as mediators of the use of hearing protection. One of these factors includes the benefits of use as one of two components reflecting declarative knowledge (factual). A sample item for this scale is "Wearing hearing protection protects me against hearing loss from noise exposure."
Barriers to Use of Hearing Protection
Time frame: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Participants' beliefs about the potential negative aspects of hearing protection device use (i.e., inconvenience, discomfort, difficulty using hearing protection devices, and interference with communication) will be assessed using a 6-item scale, which is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors that serve as mediators of the use of hearing protection. One of these factors includes the barriers to use as one of two components reflecting declarative knowledge (factual). A sample item for his scale is, 'Hearing protection keeps me from hearing what I want to hear."
Use of Hearing Protections Devices
Time frame: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
This 2-item scale will measure participants' frequency of hearing protection device use when exposed to high noise level at two time points (the past three months and one month), with data collected at baseline and at 6 and 12-month posttests. A sample item is " What percent of the time (0-100%) did you actually use ear plugs or muffs in the past three months when you were exposed to loud noise?" As the two scores for the two time points are expected to show a strong correlation, the mean of two scores will be used as the outcome variable.
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 21 Aug 2026.
- Background: PubMed 22931079Lowe J, Liang H, Riggs C, Henson J, Elder T. Community partnership to affect substance abuse among Native American adolescents. Am J Drug Alcohol Abuse. 2012 Sep;38(5):450-5. doi: 10.3109/00952990.2012.694534.
- Background: PubMed 17228988Hong O, Ronis DL, Lusk SL, Kee GS. Efficacy of a computer-based hearing test and tailored hearing protection intervention. Int J Behav Med. 2006;13(4):304-14. doi: 10.1207/s15327558ijbm1304_5.
- Background: PubMed 22161219Hong O, Chin DL, Ronis DL. Predictors of hearing protection behavior among firefighters in the United States. Int J Behav Med. 2013 Mar;20(1):121-30. doi: 10.1007/s12529-011-9207-0.
- Background: PubMed 15989167Hong O, Lusk SL, Ronis DL. Ethnic differences in predictors of hearing protection behavior between Black and White workers. Res Theory Nurs Pract. 2005 Spring;19(1):63-76. doi: 10.1891/rtnp.19.1.63.66339.
- BackgroundLowe J, Wagner E, Hospital M, et al. Utility of the Native-Reliance theoretical framework, model, and questionnaire. Journal of Cultural Diversity. 2019 26(2):61-68.
- Individual participant dataSharing planned: No
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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.
John R Lowe, RN, PHD, FAAN contact
Oi Saeng Hong, PhD, RN, FAAN, FAAOHN principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talking Circle and Diabetes prevention program & delayed TC in people with Noise-Induced Hearing Loss, run by University of California, San Francisco at 2 sites 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 5 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Oi Saeng Hong, PhD, RN, FAAN, FAAOHN (415-502-5581, OiSaeng.Hong@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy in Use of Hearing Protection (time frame: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07534098, which also lists 5 linked publications.
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 21 Aug 2026.