Impact of Hearing Aid Technology on Self-reported Outcomes
Primary Purpose
Presbycusis, Bilateral
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-end hearing aid
Basic hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Presbycusis, Bilateral focused on measuring hearing aid technology, presbycusis, self-reported outcome measures
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with presbycusis
Exclusion Criteria:
- Not being able to fill out questionnaires
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High-end hearing aid
Basic hearing aid
Arm Description
Patients will be fitted with premium level hearing aid technology
Patients will be fitted with basic level hearing aid technology
Outcomes
Primary Outcome Measures
International Outcome Inventory for Hearing Aids
Hearing aid benefit questionnaire that consists of seven questions targeting different outcome domains.
Each question is scored on a scale from 1 to 5 where a higher score indicates a better outcome.
Speech, Spatial, and Quality of hearing scale (the short form)
Hearing aid benefit questionnaire that consists of 12 questions targeting the hearing ability in different situations.
Each question is ranked on a scale from 0 to 10 where a lower score indicates a greater disability.
Secondary Outcome Measures
Full Information
NCT ID
NCT04539847
First Posted
August 31, 2020
Last Updated
October 19, 2020
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04539847
Brief Title
Impact of Hearing Aid Technology on Self-reported Outcomes
Official Title
Impact of Hearing Aid Technology on Self-reported Outcomes in Patients With Presbycusis - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbycusis, Bilateral
Keywords
hearing aid technology, presbycusis, self-reported outcome measures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-arm parallel assignment
Masking
Participant
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-end hearing aid
Arm Type
Experimental
Arm Description
Patients will be fitted with premium level hearing aid technology
Arm Title
Basic hearing aid
Arm Type
Experimental
Arm Description
Patients will be fitted with basic level hearing aid technology
Intervention Type
Device
Intervention Name(s)
High-end hearing aid
Other Intervention Name(s)
Oticon, Resound, Widex
Intervention Description
hearing aid with premium level of technology
Intervention Type
Device
Intervention Name(s)
Basic hearing aid
Other Intervention Name(s)
Oticon, Resound, Widex
Intervention Description
hearing aid with basic level of technology
Primary Outcome Measure Information:
Title
International Outcome Inventory for Hearing Aids
Description
Hearing aid benefit questionnaire that consists of seven questions targeting different outcome domains.
Each question is scored on a scale from 1 to 5 where a higher score indicates a better outcome.
Time Frame
two months
Title
Speech, Spatial, and Quality of hearing scale (the short form)
Description
Hearing aid benefit questionnaire that consists of 12 questions targeting the hearing ability in different situations.
Each question is ranked on a scale from 0 to 10 where a lower score indicates a greater disability.
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with presbycusis
Exclusion Criteria:
Not being able to fill out questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper H Schmidt, PhD, MD
Organizational Affiliation
Odense University Hospital, Region of Southern Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All personal data will become anonymized and handled with full confidentiality in compliance with the Personal Data Processing Act and GDPR. The procedure of personal data processing will be reported to the Danish Data Protection Agency (Datatilsynet) in Odense University Hospital, Region of Southern Denmark.
Learn more about this trial
Impact of Hearing Aid Technology on Self-reported Outcomes
We'll reach out to this number within 24 hrs