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ACTIVE NOT RECRUITING
NCT07092033
NA

Assessment of Customized Bimodal Stimulation for Tinnitus

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the modification of the sound stimulus to the participant's tinnitus pitch. In particular, the sound stimulus will not contain the pitch of the tinnitus, which may increase comfort and usability with the device since it will be customized to their tinnitus. Furthermore, virtual follow-up assessments and/or phone calls will be performed, thus significantly reducing the burden and personnel requirements for in-person visits as originally performed with the current clinic process.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-07-31

Completion Date

2026-07

Last Updated

2025-10-09

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Bimodal Neuromodulation

The device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. The sound is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during device fitting. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 12 weeks.

Locations (1)

University of Minnesota - PWB

Minneapolis, Minnesota, United States