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Evaluating the GN ReSound Relief App Using task-and Rest-based fMRI

NCT03888521 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-09-29

No results posted yet for this study

Summary

The main goal of this study is to assess the effectiveness of the Resound Relief app in alleviating problems associated with tinnitus, using both behavioral assessment and brain imaging. Subjective tinnitus ("ringing in the ears") is the false perception of sound in the absence of an external stimulus. It often causes emotional distress and, in severe cases, interferes with daily activities and can lead to anxiety and depression. Sound therapy and relaxation techniques have been widely used as prominent interventions to ameliorate the adverse effects of tinnitus on overall health and psychological variables. The Resound Relief app combines the merit of these two kinds of therapy to allow the patients to alternate between therapies and manipulate them according to their specifics and needs. To assess the efficacy of the Resound Relief app in relieving tinnitus, the investigators will perform an interventional study in which tinnitus patients will use the app installed on their smart phones for six months. The effects of this intervention will be quantified via audiological and cognitive assessments, administering questionnaires and surveys, and MRI scanning sessions. Audiological and cognitive assessments, and MRI scanning will be conducted before and six months after the use of the Resound Relief app. Tinnitus-related questionnaires will be administered before, two, four, and six months after beginning use of the app. A short survey will be filled out every week regarding participants' experience with the app, tracking changes in the users' tinnitus, hearing loss and general emotional well-being.

Conditions

  • Tinnitus, Subjective

Interventions

BEHAVIORAL

Resound Relief smartphone app

The intervention is a smartphone app which has been developed to include a wide range of sounds and techniques aimed at reducing the impact of tinnitus.

Sponsors & Collaborators

  • GN Hearing A/S

    collaborator INDUSTRY

  • University of Illinois at Urbana-Champaign

    lead OTHER

Principal Investigators

  • Fatima Husain, PhD · University of Illinois at Urbana-Champaign, Department of Speech and Hearing Science

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2019-12-03
Completion
2021-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03888521 on ClinicalTrials.gov