A Study Protocol for the Validation of UAud in a Clinical Setting.

November 14, 2023 updated by: University of Southern Denmark

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The project will focus on the initial examination of patients who are referred for hearing aid treatment. This initial examination consists of an audiometry which is currently conducted manually by an audiologist. However, it is possible to conduct an audiometry as a user-operated self-test by using a computer. The project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. The project will use several types of patient reported measures as well as objective measurements in the clinic. Research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination.

Also, the study will investigate whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carl Pedersen, master's degree
  • Phone Number: +4531314965
  • Email: pede@sdu.dk

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: uAud
Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry.
Diagnostic test: uAud
Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
Active Comparator: control
Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry.
Diagnostic test: Traditional audiometry
Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSQ12 (Speech, Spatial & Qualities of Hearing scale)
Time Frame: 3 months
A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HINT (Hearing In Noise Test)
Time Frame: 3 months
A performance test of patients speech intelligibility in noise.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOI-HA (International Outcome Inventory for Hearing Aids)
Time Frame: 3 months
A questionnaire regarding the patient's own perception of hearing aid outcome.
3 months
APHAB (Abbreviated Profile of Hearing Aid Benefit).
Time Frame: 3 months
A questionnaire regarding the patient's own perception of hearing and hearing aid outcome.
3 months
HINT-U (Hearing In Noise test - under amplification)
Time Frame: 3 months.
A variation of the HINT framework targeting potential under amplification of hearing aid sound level.
3 months.
HINT-O (Hearing In Noise Test - Over amplification)
Time Frame: 3 months.
A variation of the HINT framework targeting potential over amplification of hearing aid sound level.
3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Innovation Fund Denmark
William Demant Fonden

Investigators

  • Principal Investigator: Jesper Hvass Schmidt, PhD, SDU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAUD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is governed by the hospital's GPDR (General Data Protection Regulation) agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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