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

Primary Purpose

Hearing Loss, Sensorineural, Hearing Impairment, Sensorineural

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
uAud
Traditional audiometry
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Southern DenmarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

uAud

control

Arm Description

Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry.

Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry.

Outcomes

Primary Outcome Measures

SSQ12 (Speech, Spatial & Qualities of Hearing scale)
A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.

Secondary Outcome Measures

HINT (Hearing In Noise Test)
A performance test of patients speech intelligibility in noise.

Full Information

First Posted
August 30, 2021
Last Updated
November 1, 2022
Sponsor
University of Southern Denmark
Collaborators
Innovation Fund Denmark, William Demant Fonden
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1. Study Identification

Unique Protocol Identification Number
NCT05043207
Brief Title
A Study Protocol for the Validation of UAud in a Clinical Setting.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
Innovation Fund Denmark, William Demant Fonden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Hearing Impairment, Sensorineural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised control trial
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uAud
Arm Type
Experimental
Arm Description
Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry.
Arm Title
control
Arm Type
Active Comparator
Arm Description
Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry.
Intervention Type
Diagnostic Test
Intervention Name(s)
uAud
Intervention Description
Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
Traditional audiometry
Intervention Description
Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure
Primary Outcome Measure Information:
Title
SSQ12 (Speech, Spatial & Qualities of Hearing scale)
Description
A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HINT (Hearing In Noise Test)
Description
A performance test of patients speech intelligibility in noise.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
IOI-HA (International Outcome Inventory for Hearing Aids)
Description
A questionnaire regarding the patient's own perception of hearing aid outcome.
Time Frame
3 months
Title
APHAB (Abbreviated Profile of Hearing Aid Benefit).
Description
A questionnaire regarding the patient's own perception of hearing and hearing aid outcome.
Time Frame
3 months
Title
HINT-U (Hearing In Noise test - under amplification)
Description
A variation of the HINT framework targeting potential under amplification of hearing aid sound level.
Time Frame
3 months.
Title
HINT-O (Hearing In Noise Test - Over amplification)
Description
A variation of the HINT framework targeting potential over amplification of hearing aid sound level.
Time Frame
3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Pedersen, master's degree
Phone
+4531314965
Email
pede@sdu.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Hvass Schmidt, PhD
Organizational Affiliation
SDU
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Pedersen, Master's
Phone
31314965
Email
Carlp25@gmail.com
Email
Carlp25@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is governed by the hospital's GPDR (General Data Protection Regulation) agreements.

Learn more about this trial

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

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