TinnitusPhase 1/2TAGNCT02095262
Gameplay as a Source of Intrinsic Motivation in a Randomized Controlled Trial of Auditory Training for Tinnitus
A Phase 1/2 study testing reactive auditory training and Interactive auditory training in people with Tinnitus, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- reactive auditory training and Interactive auditory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic subjective tinnitus (experienced for over 6 months)
- Aged 18 + years old
- Not currently receiving treatment for tinnitus from the National Health Service or other sources
Who cannot join
- Significant distress (Beck anxiety score >25, Beck depression score >13)
- Hyperacusis (Khalfa Hyperacusis Questionnaire score >27)
- Significant bilateral hearing loss (>39 decibel at all tested frequencies)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Nottingham Hearing Biomedical Research Unit
Nottingham, NG1 5DU
About this study
Official title: 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.
- Conditions
- Tinnitus
- Being tested
- reactive auditory training, Interactive auditory training
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reactive auditory trainingOther
Interactive auditory trainingOther
| Study group | Role | What they receive |
|---|---|---|
| STAR2 | Active comparator | Reactive auditory training Receives: Other: reactive auditory training |
| Treasure Hunter | Experimental | Interactive auditory training Receives: Other: Interactive auditory training |
| Submarine | Experimental | Interactive auditory training Receives: Other: Interactive auditory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Questionnaire
Two pre-intervention assessments \& post intervention
Measured: 4 weeks
Secondary outcomes (2)
Tinnitus Handicap Inventory
Two pre-intervention assessments \& post intervention
Measured: 6 weeks
psychoacoustic measures of tinnitus
Pre and post intervention measure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Hall, Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095262
- Sponsor's protocol ID
- 11IH001
- Acronym
- TAG
- Status last verified
- Nov 2016
- First submitted
- 8 Mar 2014
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25215617Sereda 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.
PubMed 25470623
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Games for Tinnitus Benefit: Interactive Versus Reactive Auditory Discrimination Games
- ClinicalTrials.gov ID
- NCT02095262
- Acronym / sponsor ID
- TAG / 11IH001
- Conditions
- Tinnitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STAR2 | Active comparator | Other: reactive auditory trainingReactive auditory training |
| Treasure Hunter | Experimental | Other: Interactive auditory trainingInteractive auditory training |
| Submarine | Experimental | Other: Interactive auditory trainingInteractive auditory training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic subjective tinnitus (experienced for over 6 months)
- Aged 18 + years old
- Not currently receiving treatment for tinnitus from the National Health Service or other sources
Key exclusion criteria (3 listed)
- Significant distress (Beck anxiety score >25, Beck depression score >13)
- Hyperacusis (Khalfa Hyperacusis Questionnaire score >27)
- Significant bilateral hearing loss (>39 decibel at all tested frequencies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reactive auditory training | Other | STAR2 |
| Interactive auditory training | Other | Submarine, Treasure Hunter |
Primary outcome
Tinnitus Handicap Questionnaire
Time frame: 4 weeks
Two pre-intervention assessments \& post intervention
2 secondary outcomes
Tinnitus Handicap Inventory
Time frame: 6 weeks
psychoacoustic measures of tinnitus
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Results publication: PubMed 25215617Hoare 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.
- Derived from this study: PubMed 25470623Sereda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Hall, Professor principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing reactive auditory training and Interactive auditory training in people with Tinnitus, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095262, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.