NCT02095262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

March 8, 2014

Last Update Submit

November 3, 2016

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Handicap Questionnaire

    Two pre-intervention assessments \& post intervention

    4 weeks

Secondary Outcomes (2)

  • Tinnitus Handicap Inventory

    6 weeks

  • psychoacoustic measures of tinnitus

    4 weeks

Other Outcomes (1)

  • Test of Everyday Attention

    4 weeks

Study Arms (3)

STAR2

ACTIVE COMPARATOR

Reactive auditory training

Other: reactive auditory training

Treasure Hunter

EXPERIMENTAL

Interactive auditory training

Other: Interactive auditory training

Submarine

EXPERIMENTAL

Interactive auditory training

Other: Interactive auditory training

Interventions

reactive auditory trainingOTHER
STAR2
Interactive auditory trainingOTHER
SubmarineTreasure Hunter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR Nottingham Hearing Biomedical Research Unit

Nottingham, NG1 5DU, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 25215617RESULT

  • 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.

    PMID: 25470623DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Deborah Hall, Professor

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2014

First Posted

March 24, 2014

Study Start

August 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

GB(1)