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Trial registered on ANZCTR


Registration number
ACTRN12617000979358
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
6/07/2017
Date last updated
6/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial of Broad Band Noise and Nature sounds for tinnitus therapy
Scientific title
A clinical trial of Broad Band Noise and Nature sounds for tinnitus therapy: Group and individual responses modelled under the Adaptation Level Theory of Tinnitus
Secondary ID [1] 287435 0
Nil
Universal Trial Number (UTN)
U1111-1174-1176
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 296151 0
Condition category
Condition code
Ear 296426 296426 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a randomized cross-over trial. The study will involve the use of take home MP3 players and in-ear headphones, containing recorded broad-band noise (BBN) and environmental sounds for tinnitus relief, which the participant will listen to for a minimum of one hour per day for sixteen weeks (8 weeks BBN, 8 weeks environmental sounds). The long-term average loudness of BBN and environmental sounds will be equivalent. There will be a three week wash-out period in between the two conditions.
A cross-over trial design will be used to enable repeated measures of both BBN and environmental sound therapies for participants (15 participants: predictable first and 15 participants: unpredictable first). All participants will be tested by the student investigator throughout the trial.

BBN sound therapy
a) Broadband noise (BBN) set at desired listening level for comfort. Tinnitus will be audible alongside the BBN.
b) Frequency of stimulation: Minimum 1 hour per day for 8 continuous weeks
d) Mode of administration: MP3 file while participants will listen to using a Phillips ViBe 4GB MP3 player + Panasonic in-ear headphones (RP-HJE290) with Budloks Sport Grip

Environmental sound therapy
a) Environmental nature sounds (beach surf, rain, cicadas) recorded by the PI and student investigator, which vary in a random manner based one or more of the following: centre frequency, frequency relative to tinnitus, amplitude and modulation rate. Tinnitus will be audible at random time intervals alongside the nature sounds.
b) Frequency of stimulation: Minimum 1 hour per day for 8 continuous weeks
d) Mode of administration: MP3 file which participants will listen to using a Phillips ViBe 4GB MP3 player + Panasonic in-ear headphones (RP-HJE290) with Budloks Sport Grip

Follow-ups appointments were scheduled at two, four and eight weeks post fitting to monitor adherence to the intervention and changes in outcome measures over time.
Intervention code [1] 292804 0
Treatment: Devices
Intervention code [2] 292805 0
Treatment: Other
Comparator / control treatment
Broadband noise (BBN)/Environmental sounds
Control group
Active

Outcomes
Primary outcome [1] 296056 0
Tinnitus Functional Index (TFI)
Timepoint [1] 296056 0
Baseline, at 4 week follow-up and 8 week follow-up appointment for each intervention sound.
Secondary outcome [1] 317365 0
Tinnitus severity outcomes/changes: Composite measures using the Tinnitus Loudness and Severity VAS (Visual Analogue Scale), Tinnitus Handicap Questionnaire (THQ).
Timepoint [1] 317365 0
Baseline, at 4 week follow-up and 8 week follow-up appointment for each intervention sound.
Secondary outcome [2] 317366 0
Attention outcomes/changes: Composite measures using the Auditory/Visual discriminate reaction time test (DRT) and Auditory/Visual multi-processing test (AVMT) from the Computerized Attention Battery (CAB) Version 5 (Registered Trademark).
Timepoint [2] 317366 0
Baseline and at 8 week follow-up for each intervention sound.
Secondary outcome [3] 317367 0
Emotion outcomes/changes: Composite measures using the Depression, Anxiety and Stress Scale (DASS Scale), Emotion Regulation Questionnaire (ERQ), Positive and Negative Affect Schedule
Timepoint [3] 317367 0
Baseline, at 4 week follow-up and 8 week follow-up appointment for each intervention sound.
Secondary outcome [4] 317368 0
Personality traits will be assessed using the Multidimensional Personality Questionnaire – Form NZ (MPQ-Form NZ)
Timepoint [4] 317368 0
Baseline
Secondary outcome [5] 336605 0
Tinnitus psychoacoustic outcomes/changes: Composite psychoacoustic tinnitus matching using custom Tinnitus Software (® The University of Auckland): Pitch (Hz), Loudness Level Matching (dB SL), Minimum Masking Level (dB SL), 3D Location in Space,
Timepoint [5] 336605 0
Baseline, at 4 week follow-up and 8 week follow-up appointment for each intervention sound.
Secondary outcome [6] 336606 0
Tinnitus qualitative outcomes/changes: Follow-up question responses and end-of-trial interview responses at the final trial appointment. Questions relate to hours of use of sound stimuli, which particular environments the sounds were used, the perceived quality of sound stimuli, perceived interaction with and/or change in tinnitus following sound stimuli administration, preferences for which sound stimuli and why, perspectives on how sound stimuli may be improved and willingness to trial the sounds for a longer period of time.
Timepoint [6] 336606 0
Baseline, at 4 week follow-up and 8 week follow-up appointment for each intervention sound.

Eligibility
Key inclusion criteria
Adults aged between 18-65 years residing in the Auckland region with constant tinnitus and a minimum score of 38 on Tinnitus Functional Index (TFI), normal middle ear function and at maximum a moderate degree of hearing loss (less than 70 dB on average across frequencies).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age is younger than 18
- Do not experience constant tinnitus
- Presence of middle ear pathology at the time of testing (e.g. glue ear)
- Presence of a hearing loss greater than moderately severe (greater than 70 dB on average across frequencies).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Existing volunteers from the University of Auckland Tinnitus Database will be approached via email – a participant information sheet (PIS) and consent form (CF) will be attached along with the study invite. These are individuals who have expressed interest in participating in tinnitus research. Interested individuals can contact the student investigator by email or phone. Allocation was concealed in that participants were first recruited into the study and when sufficient participants were recruited, the order of sound presentation for participants (Order 1 = BBN then Nature OR Order 2 = Nature then BBN) was decided using an online, free True Random Number Generator (https://www.random.org/).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generator: True Random Number Generator (https://www.random.org/).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant numbers: Based on Wise et al. (2012, Unpublished thesis) data for tinnitus population variance, for a significant change of 13 on TFI, with mean 28.15 and standard deviation 17.1 (one-tailed), significance 0.05 and power 0.8, the sample size needed is 11 (Wise, 2012). 30 participants are therefore determined as being sufficient for this trial.

Data will be analyzed using quantitative SPSS software tools. Primary and secondary outcome scores over time following administration of each intervention sound will be analyzed (e.g. repeated measures ANOVAs) to see if they are significantly different.
Thematic analysis will be conducted on the responses provided by the participants during follow ups and during the end-of-trial interview.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/06/2015
Date of last participant enrolment
Anticipated
Actual
6/07/2015
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
30
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 7153 0
New Zealand
State/province [1] 7153 0

Funding & Sponsors
Funding source category [1] 292010 0
Charities/Societies/Foundations
Name [1] 292010 0
Deafness Research Foundation NZ
Country [1] 292010 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
University of Auckland Tamaki Campus, 261 Morrin Road, Glen Innes, Auckland 1126, NZ
Country
New Zealand
Secondary sponsor category [1] 290678 0
Other Collaborative groups
Name [1] 290678 0
Brain Research NZ
Address [1] 290678 0
C/0 CBR
The University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 290678 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293498 0
University of Auckland Human Research Ethics Committee
Ethics committee address [1] 293498 0
Ethics committee country [1] 293498 0
New Zealand
Date submitted for ethics approval [1] 293498 0
27/05/2015
Approval date [1] 293498 0
03/06/2015
Ethics approval number [1] 293498 0
014520

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60162 0
Dr Grant Searchfield
Address 60162 0
Audiology
The University of Auckland
Private bag 92019
Auckland 1142
Country 60162 0
New Zealand
Phone 60162 0
+64 9 373 7599
Fax 60162 0
Email 60162 0
[email protected]
Contact person for public queries
Name 60163 0
Grant Searchfield
Address 60163 0
Audiology
The University of Auckland
Private bag 92019
Auckland 1142
Country 60163 0
New Zealand
Phone 60163 0
+64 9 373 7599
Fax 60163 0
Email 60163 0
[email protected]
Contact person for scientific queries
Name 60164 0
Grant Searchfield
Address 60164 0
Audiology
The University of Auckland
Private bag 92019
Auckland 1142
Country 60164 0
New Zealand
Phone 60164 0
+64 9 373 7599
Fax 60164 0
Email 60164 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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