Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04539847 |
| Other study ID # |
shoumoeller |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
May 2018 |
Study information
| Verified date |
June 2020 |
| Source |
University of Southern Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study aims to investigate if the level of hearing aid (HA) technology has an impact on
self-reported outcomes in patients with presbycusis in terms of overall IOI-HA scores, Factor
1, Factor 2 scores, SSQ scores, and the SSQ domains. The study explores if presbycusis
patients report better outcomes with premium level HA technology compared to basic level HA
technology. Further, the study investigates if premium level HAs provide more high-frequency
gain than basic HAs using Real Ear Measurements.
Description:
In hearing rehabilitation clinics today, the choice of hearing aid (HA) technology level is
primarily based on the individual hearing care providers´ preferences. There is a lack of
knowledge in which level of HA technology should be chosen for patients with presbycusis and
if these patients will report higher benefit from more technologically advanced hearing aids.
Therefore, this study aims to investigate if level of hearing aid technology has an impact on
self-reported outcomes measures as the IOI-HA, SSQ, and 15-D questionnaire in patients with
presbycusis.
The study was designed as a two-arm parallel randomized controlled trial. A subgroup of
patients diagnosed with presbycusis and participating in the Danish National Better hEAring
Rehabilitation (BEAR) project was invited to participate in the study.
Data was collected from the Department of Audiology at Odense University Hospital (OUH),
Region of Southern Denmark.
All patients underwent a hearing examination which consisted of a pure-tone audiometry,
bone-conduction thresholds at 250 Hz to 4 kHz, and a measure of word recognition scores (WRS)
and speech reception thresholds (SRT) detecting the threshold at the 50% correct response
level.
The questionnaires were sent to all patients two weeks prior to the first visit in clinic and
included; a non-standardized health-related questionnaire containing questions on demographic
details such as sex, age, HA experience, motivation and the SSQ questionnaire. The IOI-HA
questionnaire was sent if patients were experienced HA users at the time of inclusion. All
questionnaires were compiled and managed using Research Electronic Data Capture (REDCap)
tools developed by Vanderbilt University, Nashville, Tennessee, United States (Harris et al.
2009, 2019) and is hosted by Odense Patient Explorative Network (OPEN) in the Region of
Southern Denmark. Patients received the questionnaires through an online link generated by
REDCap, but a paper-and-pencil version was also available if necessary when they entered the
clinic.
Patients were randomized into two groups based on age, sex and WRS, and fitted with either a
high-end or a basic level hearing aid.
Approximately two months after hearing aid fitting, a follow-up visit was scheduled where a
Real Ear Measurement (REM) was carried out. The IOI-HA and SSQ questionnaires were re-sent to
all patients two weeks prior the follow-up visit.
