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

University of Southern Denmark250 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

250

Conditions

Hearing Loss, Sensorineural Hearing Impairment, Sensorineural

Interventions

uAudDIAGNOSTIC_TEST

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

Traditional audiometryDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Southern Denmark

Odense, Funen, Denmark

RECRUITING

Outcomes

Primary Outcomes

SSQ12 (Speech, Spatial & Qualities of Hearing scale)

A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.

Time frame: 3 months

Secondary Outcomes

HINT (Hearing In Noise Test)

A performance test of patients speech intelligibility in noise.

Time frame: 3 months

Central Contacts

Carl Pedersen, master's degree

CONTACT

+4531314965 pede@sdu.dk

Data from ClinicalTrials.gov

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