Assessment of Bimodal Stimulation Device Compliance & Satisfaction in

Status Active, not recruiting

Clinical Trial 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 ability to self-adjust the sound stimulus presented to the ears via headphones. In particular, the CE marked bimodal stimulation portable device, Lenire, which is developed by Neuromod Devices Limited (Dublin, Ireland) to alleviate the symptoms of chronic subjective tinnitus, is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during fitting in a hearing center. Lenire 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. 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 10 weeks. Lenire is already commercialized across Europe and available by audiologists or hearing technicians in numerous hearing centers for treating tinnitus. It has also been evaluated in two large-scale clinical trials in over 500 tinnitus participants, demonstrating tinnitus benefit and minimal risk with high compliance and satisfaction rates. The primary objective of the proposed usability study is to first assess compliance and satisfaction with the Lenire device that does not require an audiogram for fitting and that can be implemented mostly through virtual visits (except for the first visit). These modifications to the Lenire fitting process will reduce the time and personnel effort required for its implementation, enabling a broader patient population to access bimodal stimulation for tinnitus treatment, including military personnel and those who are not nearby hearing centers for in-person sessions. High compliance and satisfaction rates from this small proof-of concept usability study will then justify and guide a larger clinical study to assess efficacy and performance of this newly implemented Lenire device process.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Tinnitus

Clinical Trial Details

NCT number	NCT05518682
Study type	Interventional
Source	University of Minnesota
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 19, 2022
Completion date	February 16, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms