A Study Protocol for the Validation of UAud in a Clinical Setting.
A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting: A Study Protocol for a Blinded Non-inferiority Randomised Controlled Trial.
1 other identifier
interventional
250
1 country
1
Brief Summary
The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 15, 2023
November 1, 2023
1 year
August 30, 2021
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
SSQ12 (Speech, Spatial & Qualities of Hearing scale)
A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.
3 months
Secondary Outcomes (1)
HINT (Hearing In Noise Test)
3 months
Other Outcomes (4)
IOI-HA (International Outcome Inventory for Hearing Aids)
3 months
APHAB (Abbreviated Profile of Hearing Aid Benefit).
3 months
HINT-U (Hearing In Noise test - under amplification)
3 months.
- +1 more other outcomes
Study Arms (2)
uAud
EXPERIMENTALPatients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry.
control
ACTIVE COMPARATORPatients which hearing aid is fitted based on the audiometry obtained with traditional audiometry.
Interventions
Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure
Eligibility Criteria
You may qualify if:
- Sensorineural hearing loss with hearing thresholds exceeding 20 dB HL at two or more frequencies in the frequency range of 0.5 to 4 kHz.
- Symmetric hearing loss with a maximum pure-tone average (PTA) (mean of 0.5-1-2-4 kHz) difference between the ears of 15 dB HL.
- Danish native speaker.
- No previous experience with HAs.
- Capable of answering questionnaires through an online mailbox.
You may not qualify if:
- Air-conduction audiometry thresholds exceeding 80 dB HL at two or more frequencies.
- Treatment affected by conductive hearing loss (air-bone gap \>10 dB on more than one frequency below 1 kHz).
- Conditions with fluctuating hearing loss, e.g., Menière's, on-going treatment with ototoxic drugs.
- Ear, nose, or throat surgery in the past 12 months.
- Evidence that the participant has made minor use of the HAs during the study (e.g., \< 2h per day).
- Visual or motor impairment that might affect the use of the UAud system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Innovation Fund Denmarkcollaborator
- William Demant Fondencollaborator
Study Sites (1)
University of Southern Denmark
Odense, Funen, 5000, Denmark
Related Publications (2)
Pedersen C, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Schmidt JH. Comparison of hearing-aid effectiveness based on user-operated versus traditional audiometry: a randomised clinical trial. Int J Audiol. 2024 Dec 2:1-8. doi: 10.1080/14992027.2024.2434897. Online ahead of print.
PMID: 39620470DERIVEDPedersen CC, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Sidiras C, Pedersen RG, Schmidt JH. Comparison of hearing aid fitting effectiveness with audiograms from either user-operated or traditional audiometry in a clinical setting: a study protocol for a blinded non-inferiority randomised controlled trial. BMJ Open. 2023 Mar 2;13(3):e065777. doi: 10.1136/bmjopen-2022-065777.
PMID: 36863737DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper Hvass Schmidt, PhD
SDU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- The HA fitting procedure will be blinded, so neither the participant, the audiologist, nor the follow up test examiner knows which group the participant belongs to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2021
First Posted
September 14, 2021
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
December 1, 2024
Last Updated
November 15, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
Data is governed by the hospital's GPDR (General Data Protection Regulation) agreements.