Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001754831
Ethics application status
Approved
Date submitted
19/11/2021
Date registered
22/12/2021
Date last updated
15/08/2023
Date data sharing statement initially provided
22/12/2021
Date results information initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of the Oticon Tinnitus Sound Support feature in hearing aids for adults with hearing loss and tinnitus.
Scientific title
A 3 month trial of the Oticon Tinnitus Sound Support feature in hearing aids for adults with hearing loss and tinnitus using the Tinnitus Functional Index as the primary outcome measure.
Secondary ID [1] 305571 0
Oticon tinnitus Sound Support trial
Universal Trial Number (UTN)
U1111-1266-8207
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 323986 0
Hearing loss (deafness) 323987 0
Condition category
Condition code
Ear 321487 321487 0 0
Other ear disorders
Ear 321488 321488 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is the fitting of hearing aids. These hearing aids have an option of turning on tinnitus therapy sounds (e.g. white noise, pink noise) these sounds resemble a constant rain sound and provide relief (masking) from tinnitus. The study will investigate whether different settings on Oticon "More" hearing aids (amplification and/or therapy sounds) provide relief as indexed by questionnaires. The settings and methods are described in a detailed protocol attached. The materials that will be used in the intervention will include a pair of appropriately fitted hearing aids tuned to the participants hearing loss along with batteries and supplies to maintain the use of the hearing aids. Participants will be provided with counselling as to how to use the aids and maintain them. Following screening of suitability and assessment of hearing and tinnitus the aids will be fit according to best practice including the measurement of real-ear-measures to ascertain acoustic suitability. The participant will be followed for further tuning of the aids and to complete the protocol steps. The hearing aids will be fit by AP Grant Searchfield and a research fellow/audiologist (TBD). AP Searchfield is an audiologist with 30 years of hearing aid fitting experience.The hearing aids will be provided face to face, some follow support will be offered over email/phone if needed between scheduled appointments.

The study consists of three clinical visits, where visit 1 comprises of a tinnitus and hearing assessment and a hearing aid fitting (90 minutes). Following this, participants will wear the devices for a three-month trial, in which a clinical follow-up visit (30 mins) is scheduled after three weeks, plus the option of an additional follow-up if needed. These one-or-two follow-ups are to adhere with normal clinical practice and to adjust the program order to suit your preference. Visit 3 is a follow-up and final visit. Participants will be requested to wear the hearing aids for a minimum 8 hours per day (total, not consecutive).
Intervention code [1] 321968 0
Treatment: Devices
Comparator / control treatment
Open trial, no control. Within participant design. Outcomes will be compared to similar research using the same outcome measures.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329263 0
Tinnitus Functional Index
Timepoint [1] 329263 0
3 months after intervention - hearing aid fitting.
Secondary outcome [1] 401947 0
Client Oriented Scale of Improvement in Tinnitus
Timepoint [1] 401947 0
3 months after intervention - hearing aid fitting.
Secondary outcome [2] 403197 0
Tinnitus Handicap Inventory
Timepoint [2] 403197 0
3 months after intervention - hearing aid fitting.
Secondary outcome [3] 403198 0
Depression and Anxiety Severity Scale.
Timepoint [3] 403198 0
3 months after intervention - hearing aid fitting.
Secondary outcome [4] 403199 0
SSQ-12 Hearing aid questionnaire
Timepoint [4] 403199 0
3 months after intervention - hearing aid fitting.
Secondary outcome [5] 403200 0
IOI-HA - a questionnaire about hearing aids
Timepoint [5] 403200 0
3 months after intervention - hearing aid fitting.

Eligibility
Key inclusion criteria
Inclusion criteria were: Adults aged 18 years or above; Chronic tinnitus (at least 6 months since onset); New and experienced HA users with a symmetric slight (16 dB HL) to moderately severe (70 dB HL) binaural symmetric (PTA4 difference between ears of 15 dB or less) sensorineural or mixed flat or sloping hearing loss; HA fitting level for the 60- or 85-dB speaker and domes, or custom moulds including all types and configurations of hearing loss; Scores in the range of ‘Normal to Severe’ in each of the three categories on the Depression Anxiety and Stress Scale – 21 Items (DASS 21).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absence of tinnitus or hearing loss. A score of ‘Extremely Severe’ in any one of the three categories of the DASS 21; Objective, pulsatile tinnitus.

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Order of program allocation randomised across cohort, order counterbalanced (crossed-over) within participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 40 participants were included in this study. 21 of the participants were new hearing aid users, 19 were experienced hearing aid users. All but one of the experienced users had used their hearing aid for at least 6 months.

Power analysis (G*Power 3.1.9.4) were based on two-tailed t-tests. Power analyses indicated that larger sample sizes were required to detect meaningful effect sizes on the SSQ-12 (hearing-related measures out of the scope of this article) (40,41) than for the tinnitus-related measures. Therefore, sample sizes were based on the SSQ-12 power analyses that indicated that at least 19 participants were required to be current HA users (for an effect size of 0.7, alfa = 0.05, and power = 0.8), and at least 9 were required to have not used HAs prior to enrolling in the study (for an effect size of 1.15, alfa = 0.05, and power = 0.8). Therefore, the minimum sample size was estimated to be N = 28, however, recruitment aimed to enroll 40 participants, to account for drop out and large variations in parameters around the test subject in tinnitus studies (e.g., severity of symptoms, psychological stress amongst participants, HA use and experience, hearing loss configurations, etc.).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2022
Actual
21/01/2022
Date of last participant enrolment
Anticipated
31/03/2022
Actual
24/08/2022
Date of last data collection
Anticipated
30/06/2022
Actual
12/12/2022
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24232 0
New Zealand
State/province [1] 24232 0
Auckland

Funding & Sponsors
Funding source category [1] 309933 0
Commercial sector/Industry
Name [1] 309933 0
Oticon
Country [1] 309933 0
Denmark
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 310970 0
None
Name [1] 310970 0
Address [1] 310970 0
Country [1] 310970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309652 0
Northern B Health and Disabilities Ethics Committee
Ethics committee address [1] 309652 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 309652 0
New Zealand
Date submitted for ethics approval [1] 309652 0
28/09/2021
Approval date [1] 309652 0
10/11/2021
Ethics approval number [1] 309652 0
21/NTB/233

Summary
Brief summary
The primary goal for this study is to assess the clinical performance of the Tinnitus Sound Support feature of the Oticon "More" hearing aid. It will examine if the hearing aid achieves the intended purpose of providing temporary relief from tinnitus. The study will also assess if the hearing aids achieve the intended purpose of helping hearing. Four different listening programs combining sound amplification and tinnitus therapy sounds will be provided to try.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114910 0
A/Prof Grant Searchfield
Address 114910 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 114910 0
New Zealand
Phone 114910 0
+64 021 877 949
Fax 114910 0
NA
Email 114910 0
g.searchfield@auckland.ac.nz
Contact person for public queries
Name 114911 0
A/Prof Grant Searchfield
Address 114911 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 114911 0
New Zealand
Phone 114911 0
+64 021 877 949
Fax 114911 0
NA
Email 114911 0
g.searchfield@auckland.ac.nz
Contact person for scientific queries
Name 114912 0
A/Prof Grant Searchfield
Address 114912 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 114912 0
New Zealand
Phone 114912 0
+64 09 373 7599
Fax 114912 0
NA
Email 114912 0
g.searchfield@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Commercial sensitivity


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 382963-(Uploaded-29-06-2023-08-55-59)-Basic results summary.docx
Plain language summaryNo Results confirm previous findings that hearing aid... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIHearing aids with tinnitus sound support reduce tinnitus severity for new and experienced hearing aid users2023https://doi.org/10.3389/fauot.2023.1238164
N.B. These documents automatically identified may not have been verified by the study sponsor.