Clinical trial NCT05043207: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Impairment, Sensorineural
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
name: William Demant Fonden
First posted: 2021-09-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised control trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: SSQ12 (Speech, Spatial & Qualities of Hearing scale)
timeFrame: 3 months
Secondary outcomes:
measure: HINT (Hearing In Noise Test)
timeFrame: 3 months
Other outcomes:
measure: IOI-HA (International Outcome Inventory for Hearing Aids)
timeFrame: 3 months
measure: APHAB (Abbreviated Profile of Hearing Aid Benefit).
timeFrame: 3 months
measure: HINT-U (Hearing In Noise test - under amplification)
timeFrame: 3 months.
measure: HINT-O (Hearing In Noise Test - Over amplification)
timeFrame: 3 months.
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Funen
Study officials:
affiliation: SDU
name: Jesper Hvass Schmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References: