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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05280808




Registration number
NCT05280808
Ethics application status
Date submitted
23/02/2022
Date registered
15/03/2022

Titles & IDs
Public title
Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
Scientific title
Device Clinical Trial of the Efficacy of Using Novel Remote Self-fitting Software Compared With Standard Remote Fitting Software in the Customisation of Hearing-aid Settings for Adults With Hearing Loss
Secondary ID [1] 0 0
SRF-385
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Experimental phone app used for self-fitting of hearing aids

Experimental: Experimental phone app - Experimental phone app for self-fitting of hearing aids


Treatment: Devices: Experimental phone app used for self-fitting of hearing aids
This software allows participants to set up hearing aids as appropriate for their hearing loss
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in speech perception after 30 days
Timepoint [1] 0 0
Day 1 and Day 30
Primary outcome [2] 0 0
Change in self-rated hearing ability after 30 days
Timepoint [2] 0 0
Day 1 and Day 30
Primary outcome [3] 0 0
Softest sounds that can be heard
Timepoint [3] 0 0
Day 1
Secondary outcome [1] 0 0
Change in preferences for fitted settings and fitting method over 30 days
Timepoint [1] 0 0
Day 1, Day 10, Day 20 and Day 30.
Secondary outcome [2] 0 0
Change in experimental self-fitting phone app use over 30 days
Timepoint [2] 0 0
Days 1-30

Eligibility
Key inclusion criteria
* Online client
* Daily aid use
* Bilateral aid use
* Uses P70-R or P90-R aids (same model both ears)
* Does not use earmolds
* Uses same soft tip on both aids
* Owns iPhone7/iOS12 or later
* Willing to install prototype app on own phone and use it in study
* Willing to participate in study for 30 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Dexterity or cognitive issues that would be problematic for using the app in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/11/2022
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Support Office and Clinic/Teleaudiology - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sonova AG
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sonova Audiological Care Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Justin A Zakis, PhD
Address 0 0
Sonova Audiological Care Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05280808