Gameplay as a Source of Intrinsic Motivation in a Randomized Controlled Trial of Auditory Training for Tinnitus

Study Overview
=================
Brief Summary
-----------------
Tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there being no such sound in the external world. It is prevalent and for many individual is a distressing condition. Recent advances in the understanding of changes in the hearing brain and their relation to tinnitus perception has led to a focus on forms of active auditory training which might provide effective techniques for tinnitus management. Our recent trial of auditory training provided evidence that training using sounds where there is no hearing loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there is some level of hearing loss. Our next challenge is to build on this finding in ways that might maximize the benefits we observe. The training software we used previously was developed for use with children. Past participants have given mixed reviews of this software. While some enjoyed the training or found it soporific, others reported that they found it too monotonous and un-motivating. We therefore wish to explore the impact of different game mechanics in the delivery of auditory training and have designed two different interactive games in the context of training for tinnitus benefit. These games will deliver the same type of auditory training as the software we currently use, but should be intrinsically motivating, i.e. be a game that the people are motivated to play irrespective of any potential benefit for tinnitus. The game we previously used is reactive, i.e. the sounds play and the player selects what they think is the correct answer (odd one out). The two new games we wish to test can be described as interactive, i.e. players control the sound delivery and actively seek the correct answer: this may have additional benefit for tinnitus.

Official Title
-----------------
Auditory Games for Tinnitus Benefit: Interactive Versus Reactive Auditory Discrimination Games

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Other: reactive auditory training
* Other: Interactive auditory training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (i) Chronic subjective tinnitus (experienced for over 6 months) (ii) Aged 18 + years old (iii) Not currently receiving treatment for tinnitus from the National Health Service or other sources Exclusion Criteria: (i) Significant distress (Beck anxiety score >25, Beck depression score >13) (ii) Hyperacusis (Khalfa Hyperacusis Questionnaire score >27) (iii) Significant bilateral hearing loss (>39 decibel at all tested frequencies)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STAR2<br>Reactive auditory training | Other: reactive auditory training<br> <br> |
| Experimental: Treasure Hunter<br>Interactive auditory training | Other: Interactive auditory training<br> <br> |
| Experimental: Submarine<br>Interactive auditory training | Other: Interactive auditory training<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Questionnaire | Two pre-intervention assessments & post intervention | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory | Two pre-intervention assessments & post intervention | 6 weeks | 
| psychoacoustic measures of tinnitus | Pre and post intervention measure | 4 weeks |