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

NCT ID: NCT03888521

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2021-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Resound Relief

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

Group Type: EXPERIMENTAL

Resound Relief smartphone app

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Screening questionnaires:

Exclusion Criteria

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.

Drug/alcohol abuse will be assessed by questions 31 and 32 in the THH Form. If a subject indicates 'yes' to question 32, indicating that they have abused drugs or alcohol within the last 2 years, those participants will be excluded from the study. Studies have shown that a history of drug or alcohol abuse affects brain patterns as measured by MRI. Because the investigators need to average in order to report our results, outliers can change our results. For this reason, the investigators ask question 31 regarding past drug and alcohol use to better understand our data set. Exclusion, however, will only be based on usage within the last 2 years (question 32). The questionnaire also asks for a list of medications currently being used; some are known to affect tinnitus, and participants using such medications will be excluded.

• 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.
• BIC safety screening form: This questionnaire contains questions regarding claustrophobia and whether there are any metal implants or pieces (such as metal flakes in the eyes from metal work) that may pose a health risk under the strong magnetic fields used in MRIs. Participants that indicate having metal in their bodies will be excluded. Those that indicate claustrophobia will be assessed for inclusion via the mock scan (see below).

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GN Hearing A/S

INDUSTRY

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Fatima Husain

Associate Professor, Department of Speech and Hearing Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatima Husain, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Countries

United States

Other Identifiers

18895

Identifier Type: -

Identifier Source: org_study_id