NCT06508060

Bimodal Stimulation Using Auditory and Vibrotactile Stimuli for the Mitigation of Tinnitus

A Randomized Controlled Trial Investigating the Efficacy and Safety of a Device That Uses Bimodal Stimulation, Consisting of Auditory and Vibrotactile Stimuli, for the Mitigation of Tinnitus

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Neosensory · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist works to treat moderate to severe tinnitus in adults. It will also learn about the safety of the device. The main questions it aims to answer are: 1. Does a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist decrease the severity of tinnitus symptoms in adults with moderate to severe tinnitus? 2. What medical problems do participants report when using a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist? Researchers will compare a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist to a control condition in which only auditory tones are used, without the device, to see if the bimodal stimulation device works to treat moderate to severe tinnitus. Participants will: 1. Use the bimodal stimulation device for 10 minutes every day for a period of 8 weeks 2. Have one-on-one calls with the research team at the beginning and end of the study 3. Complete baseline and final tinnitus functional index assessments to track progress as a result of the intervention.

Detailed description

Our research hypothesis is, randomized tones coupled with a spatial spread of vibrotactile signals on the wrist to deliver bimodal stimulation will decrease the severity of tinnitus symptoms as measured by a clinically significant improvement on the Tinnitus Functional Index questionnaire (TFI). We also hypothesize this treatment will prove to be safe, with minimal or no side effects. We will recruit adults in the United States who respond to an online advertisement that mentions a study investigating a new tinnitus treatment. A total of 200 participants will be confirmed and randomly assigned to a wristband condition or an audio-only control condition (100 participants per condition). Each participant will complete ten minutes of treatment daily over the course of the eight-week study. The treatment will include listening to tones and, unless in the control condition, feeling corresponding vibrations on the wrist. In the control condition, participants will listen to tones without additional vibrotactile stimulation from a wristband. Participants will complete the TFI questionnaire at baseline prior to starting treatment with Duo and after 8 weeks of treatment.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	Neosensory Wristband	The Neosensory wristband consists of four vibratory motors built into the strap of the wristband (Figure 1a). The motors are linear resonant actuators (LRAs), vibrating at 175 Hz, capable of rising from 0 to 50% of their intensity within 30 ms. The motor intensity can be controlled with an eight bit resolution, meaning each motor can be controlled at 256 different intensities. At the highest intensity, each motor vibrates at 1.7 GRMS. The motors are separated from one another at a distance of 18.2 mm and 19.2 mm for the small and large wristband sizes, respectively (center-to-center distances). The top of the wristband is a module that contains the power button, user setting buttons, a microphone, and a microcontroller. Bluetooth communication is used to create the corresponding vibrations on the wristband. While the study app plays the tones, it also sends a Bluetooth command to the wristband such that the wristband vibrates in the appropriate illusory location.
OTHER	Tones only	Tones will be played through an app

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2024-07-18
• Last updated: 2024-07-18

Regulatory

• FDA-regulated device study