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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hearing Loss, Sensorineural Hearing Impairment, Sensorineural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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uAud

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

Group Type EXPERIMENTAL

uAud

Intervention Type DIAGNOSTIC_TEST

Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure

control

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

Group Type ACTIVE_COMPARATOR

Traditional audiometry

Intervention Type DIAGNOSTIC_TEST

Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure

Interventions

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uAud

Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure

Intervention Type DIAGNOSTIC_TEST

Traditional audiometry

Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes