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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
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 31, 2020
    Last Updated
    October 19, 2020
    Sponsor
    University of Southern Denmark
    Collaborators
    Odense University Hospital
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    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.

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    Impact of Hearing Aid Technology on Self-reported Outcomes

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