Presbycusis, BilateralNCT04539847
Impact of Hearing Aid Technology on Self-reported Outcomes
A study testing High-end hearing aid and Basic hearing aid in people with Presbycusis, Bilateral, run by University of Southern Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbycusis, Bilateral
- What is being tested?
- High-end hearing aid and Basic hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with presbycusis
Who cannot join
- Not being able to fill out questionnaires
About this study
Official title: Impact of Hearing Aid Technology on Self-reported Outcomes in Patients With Presbycusis - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Presbycusis, Bilateral
- Being tested
- High-end hearing aid, Basic hearing aid
- Keywords
- hearing aid technology, presbycusis, self-reported outcome measures
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-end hearing aidDevice
Also called Oticon, Resound, Widex
hearing aid with premium level of technology
Basic hearing aidDevice
Also called Oticon, Resound, Widex
hearing aid with basic level of technology
| Study group | Role | What they receive |
|---|---|---|
| High-end hearing aid | Experimental | Patients will be fitted with premium level hearing aid technology Receives: Device: High-end hearing aid |
| Basic hearing aid | Experimental | Patients will be fitted with basic level hearing aid technology Receives: Device: Basic hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months
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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study startDec 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Presbycusis, BilateralStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Jesper H Schmidt, PhD, MD, Principal investigator, Odense University Hospital, Region of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539847
- Sponsor's protocol ID
- shoumoeller
- Status last verified
- Jun 2020
- First submitted
- 31 Aug 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Houmoller SS, Wolff A, Tsai LT, Narayanan SK, Hougaard DD, Gaihede ML, Neher T, Godballe C, Schmidt JH. Impact of hearing aid technology level at first-fit on self-reported outcomes in patients with presbycusis: a randomized controlled trial. Front Aging. 2023 Jun 1;4:1158272. doi: 10.3389/fragi.2023.1158272. eCollection 2023.
PubMed 37342862
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hearing Aid Technology on Self-reported Outcomes in Patients With Presbycusis - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04539847
- Acronym / sponsor ID
- shoumoeller
- Conditions
- Presbycusis, Bilateral
- Keywords
- hearing aid technology, presbycusis, self-reported outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two-arm parallel assignment
| Arm | Type | Receives |
|---|---|---|
| High-end hearing aid | Experimental | Device: High-end hearing aidPatients will be fitted with premium level hearing aid technology |
| Basic hearing aid | Experimental | Device: Basic hearing aidPatients will be fitted with basic level hearing aid technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with presbycusis
Key exclusion criteria (1 listed)
- Not being able to fill out questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-end hearing aidAlso: Oticon, Resound, Widexhearing aid with premium level of technology | Device | High-end hearing aid |
| Basic hearing aidAlso: Oticon, Resound, Widexhearing aid with basic level of technology | Device | Basic hearing aid |
Primary outcome
International Outcome Inventory for Hearing Aids
Time frame: two months
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)
Time frame: two months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Derived from this study: PubMed 37342862Houmoller SS, Wolff A, Tsai LT, Narayanan SK, Hougaard DD, Gaihede ML, Neher T, Godballe C, Schmidt JH. Impact of hearing aid technology level at first-fit on self-reported outcomes in patients with presbycusis: a randomized controlled trial. Front Aging. 2023 Jun 1;4:1158272. doi: 10.3389/fragi.2023.1158272. eCollection 2023.
- Individual participant dataSharing planned: No. 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.
Related trials for Presbycusis, Bilateral
Enrolling by invitation
Hearing Screening in Adults Over 50 Years Old
Hearing Loss, Bilateral Sensorineural, Progressive, Hearing Loss, Bilateral (Causes Other Than Tumors)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper H Schmidt, PhD, MD principal investigator
Odense University Hospital, Region of Southern Denmark
Questions about this trial
What is this clinical trial studying?
A study testing High-end hearing aid and Basic hearing aid in people with Presbycusis, Bilateral, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Outcome Inventory for Hearing Aids (time frame: two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04539847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.