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

Tinnitus Clinical Trial

— TAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095262
• Other study ID #: 11IH001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 8, 2014
• Last updated: November 3, 2016
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: November 2016
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: England: National Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Other:
• reactive auditory training

• Interactive auditory training

Locations

Country	Name	City	State
United Kingdom	NIHR Nottingham Hearing Biomedical Research Unit	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Test of Everyday Attention	Pre and post intervention	4 weeks	No
Primary	Tinnitus Handicap Questionnaire	Two pre-intervention assessments & post intervention	4 weeks	No
Secondary	Tinnitus Handicap Inventory	Two pre-intervention assessments & post intervention	6 weeks	No
Secondary	psychoacoustic measures of tinnitus	Pre and post intervention measure	4 weeks	No

External Links

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