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OpenTrials
Completed

NCT Number: NCT02095262

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

NIHR Nottingham Hearing Biomedical Research Unit

Nottingham, NG1 5DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

reactive auditory training

Other

Interactive auditory training

Other

Primary outcomes

  1. Tinnitus Handicap Questionnaire

    Time frame: 4 weeks

    Two pre-intervention assessments & post intervention

Secondary outcomes

  1. Tinnitus Handicap Inventory

    Time frame: 6 weeks

    Two pre-intervention assessments & post intervention

  2. psychoacoustic measures of tinnitus

    Time frame: 4 weeks

    Pre and post intervention measure

Other outcomes

  1. Test of Everyday Attention

    Time frame: 4 weeks

    Pre and post intervention

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Official study title

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

Acronym: TAG

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 24, 2014
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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