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

NCT03888521 | Unknown

• 1 other identifier: 18895
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Relief

Outcome Measures

Primary Outcomes (3)

• Reduced tinnitus annoyance measured via Tinnitus Functional Index

  The Tinnitus Functional Index (TFI) is a tinnitus questionnaire, widely used to quantify tinnitus annoyance. It contains 25 questions, each of which participants rate from a scale of 0-10. The scores are then averaged, to give an overall score from 0 to 100. Higher values indicate higher disturbance and annoyance from tinnitus. There are also 8 subscales in the questionnaire, which are each also averaged to give scores from 0 to 100. The subscales look at various aspects of tinnitus annoyance, specifically (1) intrusiveness, (2) reduced sense of control, (3) cognitive interference, (4) sleep disturbance, (5) auditory difficulties, (6) interference with relaxation, (7) reduced quality of life and (8) emotional distress. The questionnaire will be completed by participants before (baseline), and 2, 4 and 6 months after using the app for a minimum of 1 hour a day, 5 days a week. The investigators hope to see reduction in the reported annoyance of tinnitus in participants' lives.

  baseline, 2 months, 4 months and 6 months

• Reduced tinnitus annoyance measured via Iowa Tinnitus Primary Function Questionnaire

  The Tinnitus Primary Function Questionnaire (TPFQ) is a tinnitus questionnaire, widely used to quantify tinnitus annoyance. It contains 20 questions, each of which participants rate from a scale of 0-100. The scores are then averaged, to give an overall score from 0 to 100. Higher values indicate higher disturbance and annoyance from tinnitus. There are also 4 subscales in the questionnaire, which are each also averaged to give scores from 0 to 100. The subscales look at various aspects of tinnitus annoyance, specifically (1) difficulties in concentration, (2) emotional distress, (3) hearing difficulties, and (4) sleep difficulties. The questionnaire will be completed by participants before (baseline), and 2, 4 and 6 months after using the app for a minimum of 1 hour a day, 5 days a week. The investigators hope to see reduction in the reported annoyance of tinnitus in participants' lives.

  baseline, 2 months, 4 months and 6 months

• Reduced tinnitus annoyance measured via Tinnitus Handicap Inventory

  The Tinnitus Handicap Inventory (THI) is a tinnitus questionnaire, widely used to quantify tinnitus annoyance. It contains 25 questions, each of which participants rate one of "Yes," "Sometimes," or "No." Any "Yes" response is scored as 4 points, "Sometimes" is scored as 2 points, and "No" is scored as 0 points. The totals are then added up, giving an overall questionnaire score that can range from 0-100. Higher values indicate higher disturbance and annoyance from tinnitus. The questionnaire will be completed by participants before (baseline), and 2, 4 and 6 months after using the app for a minimum of 1 hour a day, 5 days a week. The investigators hope to see reduction in the reported annoyance of tinnitus in participants' lives.

  baseline, 2 months, 4 months and 6 months

Secondary Outcomes (3)

• Analyzing changes in neural gray matter using voxel-based morphometry (VBM)

  baseline, and 6 months

• Analyzing changes in neural white matter using diffusion tensor imaging (DTI)

  baseline, and 6 months

• Analyzing changes in resting state neural networks using functional magnetic resonance imaging

  baseline, and 6 months

Study Arms (1)

Resound Relief

EXPERIMENTAL

All participants are in the same group, and receive the same intervention - use of the Resound Relief smartphone app for 6 months

Behavioral: Resound Relief smartphone app

Interventions

Resound Relief smartphone app BEHAVIORAL

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.

Resound Relief

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening questionnaires:

You may not qualify if:

• For the purpose of this study (i.e. intervention), the investigators will include participants with managed depression or anxiety, as it may be difficult to recruit participants with severe tinnitus that do not have one or both of those conditions. However, only subjects aged between 21- 70 years old will be included.
• Tinnitus Functional Index (TFI): The investigators will recruit participants with varying degrees of tinnitus severity, reflecting the real-world usage of the app, but with a preference that at least 50% of the subjects have bothersome tinnitus defined as greater than 25 on the TFI scale (0-100).
• Audiometric evaluation (described in research procedures): The audiometric evaluation will primarily be used to obtain participants' hearing profiles. Subjects who have normal hearing thresholds (defined as less than or equal to 30 dB HL) up to 1 kHz in at least one ear will be included. Subjects who do not meet the defined normal hearing thresholds will be assessed on a case by case basis to ensure they can communicate without assistance with the investigators during scanning.
• Screening questionnaires:
• Tinnitus and Hearing Healthcare History (THH) form: This form contains questions regarding confounding variables such as traumatic brain injury (TBI), post-traumatic stress disorder, Ménière's disease, drug and alcohol use, and neurological or psychiatric health issues such as epilepsy. In the event that a participant has any of the described conditions or uses drugs/drinks to excess, those participants will be excluded from the study.
• BDI and BAI: If a subject presents with significant depression and/or anxiety those participants will be excluded. This is demonstrated via a score above 30 on the Beck Depression Inventory (BDI) and/or above 25 on the Beck Anxiety Inventory (BAI). Further, the BDI contains a question (#9) asking about suicidal thoughts. This question will not be asked and has been deleted from the questionnaire given to the subjects.
• Mini-Mental State Examination: Participants will be excluded from the study if they do not have normal cognition, i.e. if a given score of 27 out of 30 or lower is achieved on the Mini-Mental State Examination.
• Audiometric evaluation:
• Participants with hearing aids will be evaluated on a case-by-case basis as to their communication abilities without hearing aids.
• Loudness Discomfort Level: Loudness Discomfort Levels (LDLs) measured during the assessment will be used to verify whether participants will be able to tolerate the noise level of the scanner. Hearing protection will be provided during the MRI scans; however, participants with low LDLs may still experience discomfort. For their comfort, if participants report that a sound is uncomfortable at an LDL of 75 dB HL or quieter, those participants will be excluded from the MRI scanning portion of the study. If a participant has an LDL between 76 and 90 dB HL, they will be assessed on a case by case basis for comfort within the MRI scanner (the investigators will play scanner noise for the participants, take into consideration any past MRIs participants have had, etc.). If participants have an LDL of 90 dB HL or higher, those participants will be able to tolerate the noise level of the scanner and will be included.
• MRI Scans (described in research procedures):
• Mock scan: If participants meet the above criteria, they will be asked to complete a mock MRI scan. During this mock scan, participants will be placed inside a non- operational model of the MRI magnet to verify they are not claustrophobic and will be comfortable during the MRI scans.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• GN Hearing A/S: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatima Husain, PhD

  University of Illinois at Urbana-Champaign, Department of Speech and Hearing Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants receive the intervention, serving as their own controls
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Speech and Hearing Science

Model Details: Efficacy of a non-invasive intervention is being tested, while exploratory data is also being collected to better understand tinnitus

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 25, 2019
• Study Start: October 2, 2018
• Primary Completion: December 3, 2019
• Study Completion: December 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)