NCT06689865 Innovations in Hearing Accessibility and Technology (IHAT) Study
| NCT ID | NCT06689865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2024-11-13 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.
Eligibility Criteria
Inclusion Criteria: * Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation * Aged 40 years or older * No previous HA experience greater than 3 months * Able to read and understand patient education materials * Willing to be randomized to one of the four groups, and * Owns a smartphone Exclusion Criteria: * Hearing loss that is too severe for OTC HAs * Middle ear disorders or conductive pathology present * Asymmetrical hearing loss * Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the MOCA * Non-English speaking as it may impact the ability to complete our test battery
Contact & Investigator
Vinaya Manchaiah, AuD, MBA, PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06689865 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06689865 currently recruiting?
Yes, NCT06689865 is actively recruiting participants. Contact the research team at ihat@cuanschutz.edu for enrollment information.
Where is the NCT06689865 trial being conducted?
This trial is being conducted at Aurora, United States, Boulder, United States.
Who is sponsoring the NCT06689865 clinical trial?
NCT06689865 is sponsored by University of Colorado, Denver. The principal investigator is Vinaya Manchaiah, AuD, MBA, PhD at University of Colorado, Denver. The trial plans to enroll 280 participants.