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
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:
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- 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.