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NCT05518682 · ClinicalTrials.gov registry record · NA
Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT05518682 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 26 participants.
The verdict
NCT05518682, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study 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 usabi
Interventions
- DEVICE Lenire bimodal stimulation device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2025-02-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05518682
The ClinicalTrials.gov registry entry for NCT05518682 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lenire bimodal stimulation device is the first listed.
NCT05518682 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05518682 about?
NCT05518682 is a clinical study titled "Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus". 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 devi...
What is the current status of trial NCT05518682?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2022-09-19. Estimated completion is 2025-02-16.
What interventions are being tested in trial NCT05518682?
The interventions under investigation include: Lenire bimodal stimulation device (DEVICE).
Who is sponsoring clinical trial NCT05518682?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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