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

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
reactive auditory training
Interactive auditory training
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NIHR Nottingham Hearing Biomedical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

STAR2

Treasure Hunter

Submarine

Arm Description

Reactive auditory training

Interactive auditory training

Interactive auditory training

Outcomes

Primary Outcome Measures

Tinnitus Handicap Questionnaire
Two pre-intervention assessments & post intervention

Secondary Outcome Measures

Tinnitus Handicap Inventory
Two pre-intervention assessments & post intervention
psychoacoustic measures of tinnitus
Pre and post intervention measure

Full Information

First Posted
March 8, 2014
Last Updated
November 3, 2016
Sponsor
Nottingham University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02095262
Brief Title
Gameplay as a Source of Intrinsic Motivation in a Randomized Controlled Trial of Auditory Training for Tinnitus
Acronym
TAG
Official Title
Auditory Games for Tinnitus Benefit: Interactive Versus Reactive Auditory Discrimination Games
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STAR2
Arm Type
Active Comparator
Arm Description
Reactive auditory training
Arm Title
Treasure Hunter
Arm Type
Experimental
Arm Description
Interactive auditory training
Arm Title
Submarine
Arm Type
Experimental
Arm Description
Interactive auditory training
Intervention Type
Other
Intervention Name(s)
reactive auditory training
Intervention Type
Other
Intervention Name(s)
Interactive auditory training
Primary Outcome Measure Information:
Title
Tinnitus Handicap Questionnaire
Description
Two pre-intervention assessments & post intervention
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Tinnitus Handicap Inventory
Description
Two pre-intervention assessments & post intervention
Time Frame
6 weeks
Title
psychoacoustic measures of tinnitus
Description
Pre and post intervention measure
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Test of Everyday Attention
Description
Pre and post intervention
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Hall, Professor
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIHR Nottingham Hearing Biomedical Research Unit
City
Nottingham
ZIP/Postal Code
NG1 5DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25215617
Citation
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.
Results Reference
result
PubMed Identifier
25470623
Citation
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.
Results Reference
derived
Links:
URL
http://www.hearing.nihr.ac.uk/research/auditory-games-for-tinnitus-benefit/
Description
departmental page description

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

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