Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07534098

Intervention for Hearing Health Among Native Americans

The purpose of the study is to understand the cultural impact on hearing loss among Native Americans 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Noise-induced Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Noise-Induced Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United Keetoowah Band of Cherokee Indians

Tahlequah, Oklahoma, 74464, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Native American tribal member; are age 18 years and older; may work in a noisy environment; and are willing to give informed consent to participate in the study. The study will include people without hearing loss and with hearing loss as well.

Exclusion criteria

  • Younger than the age of 18, non Native American tribal member and unwillingness to give informed consent.

Treatment and study plan

Talking Circle

Behavioral

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 TC

Behavioral

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.

Primary outcomes

  1. Knowledge of Noise-Induced Hearing Loss

    Time frame: Data collected at 3 time points: baseline enrollment, and at 6 and 12-month posttests.

    Knowledge of NIHL will be assessed by benefits and barriers (3-item and 6-item, 5-point Likert scales, respectively) of Use of Hearing Protection as reflecting declarative knowledge (factual), and self-efficacy (2-item, 5-point Likert scale) in Use of Hearing Protection as reflecting procedure knowledge (how to do).

  2. Use of Hearing Protections Devices (HPDs)

    Time frame: Data collected at baseline enrollment and at 6 and 12-month posttests.

    Mean use of HPDs will be calculated using the participant's use of HPDs in percentage of the time (0%-100%) when in loud noise at two time points (the past three months and one month) measured at pretest and at 6 and 12-month posttests. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

John R Lowe, RN, PHD, FAAN

CONTACT

[email protected]

Oi Saeng Hong, PhD, RN, FAAN, FAAOHN

CONTACT

[email protected]

415-502-5581

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • University of Texas at Austin

Registry information

Acronym: IHHANA

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.