Validation of a user-operated audiometry system for hearing rehabilitation
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.
NA · University of Southern Denmark · NCT05043207
This study is testing a new user-operated hearing test system to see if it works as well as traditional methods for helping people who need hearing aids.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark (other) |
| Locations | 1 site (Odense, Funen) |
| Trial ID | NCT05043207 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the User-operated Audiometry (UAud) system in a clinical setting by comparing its effectiveness in hearing rehabilitation to traditional audiometry methods. Patients referred for hearing aid treatment will undergo both user-operated and manual audiometry tests to assess if the outcomes are equivalent. The study will also evaluate the correlation between thresholds obtained from the UAud system and traditional measures of speech intelligibility. By utilizing patient-reported measures alongside objective clinical assessments, the research seeks to determine the quality of hearing aid treatment based on different examination methods.
Who should consider this trial
Good fit: Ideal candidates include Danish native speakers with sensorineural hearing loss exceeding 20 dB HL at multiple frequencies and no prior experience with hearing aids.
Not a fit: Patients with conductive hearing loss, fluctuating hearing conditions, or significant visual or motor impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and efficient method for hearing rehabilitation, potentially improving patient outcomes.
How similar studies have performed: While the approach of user-operated audiometry is innovative, similar studies have shown promise in validating self-administered tests in other medical fields.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Odense, Funen
- University of Southern Denmark — Odense, Funen, Denmark (RECRUITING)
Study contacts
- Principal investigator: Jesper Hvass Schmidt, PhD — SDU
- Study coordinator: Carl Pedersen, master's degree
- Email: pede@sdu.dk
- Phone: +4531314965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Loss, Sensorineural, Hearing Impairment, Sensorineural