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

Auditory Games for Tinnitus Benefit: Interactive Versus Reactive Auditory Discrimination Games

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Other: reactive auditory training; Other: Interactive auditory training

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG1 5DU
    • NIHR Nottingham Hearing Biomedical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: STAR2; Reactive auditory training	Other: reactive auditory training
Experimental: Treasure Hunter; Interactive auditory training	Other: Interactive auditory training
Experimental: Submarine; Interactive auditory training	Other: Interactive auditory training

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of Everyday Attention	Pre and post intervention	4 weeks

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: Deborah Hall, Professor, University of Nottingham

Publications and helpful links

General Publications

• Hoare DJ, Van Labeke N, McCormack A, Sereda M, Smith S, Al Taher H, Kowalkowski VL, Sharples M, Hall DA. Gameplay as a source of intrinsic motivation in a randomized controlled trial of auditory training for tinnitus. PLoS One. 2014 Sep 12;9(9):e107430. doi: 10.1371/journal.pone.0107430. eCollection 2014.
• Sereda M, Edmondson-Jones M, Hall DA. Relationship between tinnitus pitch and edge of hearing loss in individuals with a narrow tinnitus bandwidth. Int J Audiol. 2015 Apr;54(4):249-56. doi: 10.3109/14992027.2014.979373. Epub 2014 Dec 3.

Helpful Links

• departmental page description

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: March 8, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 11IH001