Hearing LossNCT02448706
Variability In Hearing Aid Outcomes In Older Adults
A study testing Hearing Aid Fitting A and Hearing Aid Fitting B in people with Hearing Loss and Presbycusis, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss. Read more about this study
- Who is it for?
- Ages 54 years and older
- Conditions the study is for
- Hearing Loss, Presbycusis
- What is being tested?
- Hearing Aid Fitting A and Hearing Aid Fitting B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 54 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL
- Non hearing aided wearer within the previous year
- Participants will be in good health (self-report)
- Normal or corrected to normal vision(≤20/50)
Who cannot join
- Conductive, or asymmetric hearing loss
- Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
- Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
- Significant history of otologic or neurologic disorders
- Non English speaking participants
- Score of 23 or below on Mini-Mental Status Exam (MMSE)
Show all 10Show fewer
- Score of 22 or below on Montreal Cognitive Assessment (MoCA)
- Any clinically significant unstable or progressive medical condition
- Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
- Participants will be divided into low and high working groups based upon the results of their Lunner working memory reading span test. Once either high or low working memory group is filled (approximately 25 participants) we will selectively enroll participants to fill the other category.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Boulder
Boulder, Colorado, 80309
About this study
Official title: Characterizing Variability in Hearing Aid Outcomes Among Older Adults
The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.
Read the detailed description
Response to hearing aids is highly variable, with some individuals reporting much more benefit than others. Preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. The long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.
- Conditions
- Hearing Loss, Presbycusis
- Being tested
- Hearing Aid Fitting A, Hearing Aid Fitting B
- Keywords
- hearing aid
- Medical subject headings
- Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid Fitting ADevice
Also called Hearing Aid
Hearing Aid Fitting BDevice
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid Fitting Order A | Active comparator | High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. Receives: Device: Hearing Aid Fitting A; Device: Hearing Aid Fitting B |
| Hearing Aid Fitting Order B | Active comparator | Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. Receives: Device: Hearing Aid Fitting A; Device: Hearing Aid Fitting B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility Score
Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.
Measured: 6 weeks
Secondary outcomes (3)
Effectiveness of Aural Rehabilitation (EAR)
The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).
Measured: 6 weeks
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.
Measured: 6 weeks
Adherence
Average number of hours per day the hearing aid was worn.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Pamela Souza, Northwestern University
- Investigators
- Pamela E Souza, PhD, Principal investigator, Northwestern UniversityKathryn H Arehart, PhD, Principal investigator, University of Colorado at Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448706
- Sponsor's protocol ID
- 1R01DC012289-01
- Other IDs
- 1R01DC012289-01
- Status last verified
- Oct 2020
- First submitted
- 15 May 2015
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Anderson M, Rallapalli V, Schoof T, Souza P, Arehart K. The use of self-report measures to examine changes in perception in response to fittings using different signal processing parameters. Int J Audiol. 2018 Nov;57(11):809-815. doi: 10.1080/14992027.2018.1490035. Epub 2018 Jul 27.
PubMed 30052097
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Variability in Hearing Aid Outcomes Among Older Adults
- ClinicalTrials.gov ID
- NCT02448706
- Acronym / sponsor ID
- 1R01DC012289-01
- Conditions
- Hearing Loss, Presbycusis
- Keywords
- hearing aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Posted 14 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.
Detailed description
Response to hearing aids is highly variable, with some individuals reporting much more benefit than others. Preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. The long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid Fitting Order A | Active comparator | Device: Hearing Aid Fitting A, Device: Hearing Aid Fitting BHigh level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. |
| Hearing Aid Fitting Order B | Active comparator | Device: Hearing Aid Fitting A, Device: Hearing Aid Fitting BLow level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. |
Who may qualify
- Ages
- 54 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL
- Non hearing aided wearer within the previous year
- Participants will be in good health (self-report)
- Normal or corrected to normal vision(≤20/50)
Key exclusion criteria (10 listed)
- Conductive, or asymmetric hearing loss
- Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
- Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
- Significant history of otologic or neurologic disorders
- Non English speaking participants
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 |
|---|---|---|
| Hearing Aid Fitting AAlso: Hearing Aid | Device | Hearing Aid Fitting Order A, Hearing Aid Fitting Order B |
| Hearing Aid Fitting B | Device | Hearing Aid Fitting Order A, Hearing Aid Fitting Order B |
Primary outcome
Speech Intelligibility Score
Time frame: 6 weeks
Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.
3 secondary outcomes
Effectiveness of Aural Rehabilitation (EAR)
Time frame: 6 weeks
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
Time frame: 6 weeks
Adherence
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30052097Anderson M, Rallapalli V, Schoof T, Souza P, Arehart K. The use of self-report measures to examine changes in perception in response to fittings using different signal processing parameters. Int J Audiol. 2018 Nov;57(11):809-815. doi: 10.1080/14992027.2018.1490035. Epub 2018 Jul 27.
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
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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.
Pamela E Souza, PhD principal investigator
Northwestern University
Kathryn H Arehart, PhD principal investigator
University of Colorado at Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid Fitting A and Hearing Aid Fitting B in people with Hearing Loss and Presbycusis, run by Northwestern University at 1 site in United States.
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 4 inclusion and 10 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Speech Intelligibility Score (time frame: 6 weeks). 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 NCT02448706, 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 17 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.