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

NCT ID: NCT02095262

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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STAR2

Reactive auditory training

Group Type ACTIVE_COMPARATOR

reactive auditory training

Intervention Type OTHER

Treasure Hunter

Interactive auditory training

Group Type EXPERIMENTAL

Interactive auditory training

Intervention Type OTHER

Submarine

Interactive auditory training

Group Type EXPERIMENTAL

Interactive auditory training

Intervention Type OTHER

Interventions

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reactive auditory training

Intervention Type OTHER

Interactive auditory training

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Hall, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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NIHR Nottingham Hearing Biomedical Research Unit

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 25215617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25470623 (View on PubMed)

Related Links

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Other Identifiers

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11IH001

Identifier Type: -

Identifier Source: org_study_id