Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06508060
Brief 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.
Study:
NCT06508060
Study Brief:
Protocol Section:
NCT06508060