Tinnitus, Subjective
Conditions
Keywords
Relief
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.
Interventions
BEHAVIORALResound 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
GN Hearing A/S
University of Illinois at Urbana-Champaign
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
All participants receive the intervention, serving as their own controls
Intervention model description
Efficacy of a non-invasive intervention is being tested, while exploratory data is also being collected to better understand tinnitus
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Screening questionnaires: * Tinnitus and Hearing Healthcare History (THH) form: This form is intended to assess subjects' healthcare history. The manner in which it is used to exclude subjects due to health issues other than tinnitus and hearing loss is described in the
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced tinnitus annoyance measured via Tinnitus Functional Index | baseline, 2 months, 4 months and 6 months | 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. |
| Reduced tinnitus annoyance measured via Iowa Tinnitus Primary Function Questionnaire | baseline, 2 months, 4 months and 6 months | 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. |
| Reduced tinnitus annoyance measured via Tinnitus Handicap Inventory | baseline, 2 months, 4 months and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analyzing changes in neural gray matter using voxel-based morphometry (VBM) | baseline, and 6 months | Voxel-based morphometry (VBM) is a computational analytical technique that measures differences in local concentrations of brain tissue. VBM is applied to high-resolution anatomical images collected via magnetic resonance imaging. The unit of this measurement is mm3 of original grey matter per mm3 of spatially normalised space within the participant's brain image. Whole-brain VBM comparisons will be applied within each participant's data, comparing their total gray matter brain volume before use of the smartphone app to total gray matter brain volume after 6 months of using the app. |
| Analyzing changes in neural white matter using diffusion tensor imaging (DTI) | baseline, and 6 months | Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique which enables the measurement of the movement of water molecules within tissue, allowing us to track a white matter tract and calculate its microstructural integrity. Fractional anisotropy (FA), which is a scalar value ranging from 0 to 1, is a DTI measure which allows us to calculate how freely the water molecules within a measured tissue can move. Tractography is a modeling technique used to visually represent nerve tracts within the brain, which is derived from the DTI data collected. FA will be calculated, and tractography modeled, for each participant, comparing their total white matter microstructural integrity before use of the smartphone app and after 6 months of using the app. |
| Analyzing changes in resting state neural networks using functional magnetic resonance imaging | baseline, and 6 months | Resting state functional connectivity is a functional magnetic resonance imaging technique used to evaluate interactions between various brain regions while the brain is at waking rest. The technique measures the haemodynamic response of the brain after magnetic pulses are sent by the scanner. This response is measured on a scale known as the Blood Oxygen Level Dependent (BOLD) signal, which is relative. Correlations of activity seen between brain regions is believed to be indicative of neural networks. The resting state functional connectivity will be measured for each participant, before, and after 6 months of using the app. |
Countries
United States
Outcome results
None listed