Hearing LossNCT03728907
A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
A study testing Hearing aid fitting technique- audiologist or user-adjusted in people with Hearing Loss, run by San Diego State University.
Trial summary
Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aid fitting technique- audiologist or user-adjusted
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 May 2022
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
- English speaking
Who cannot join
- Score less than 21 on the MoCa (Montreal Cognitive Assessment)
- Evidence of conductive or retrocochlear pathology
About this study
Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.
- Conditions
- Hearing Loss
- Being tested
- Hearing aid fitting technique- audiologist or user-adjusted
- Keywords
- hearing aid, self-fitting
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aid fitting technique- audiologist or user-adjustedDevice
See information under 'arm' description
| Study group | Role | What they receive |
|---|---|---|
| Audiologist-adjusted first | Active comparator | This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting. Receives: Device: Hearing aid fitting technique- audiologist or user-adjusted |
| User-adjusted first | Experimental | This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting. Receives: Device: Hearing aid fitting technique- audiologist or user-adjusted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-ear aided output
aided output (in dB SPL) measured across frequencies in the ears of the participants
Measured: two weeks
Secondary outcomes (2)
Device Oriented Scale of Improvement (DOSO)
Questionnaire (25 items) to assess benefit from hearing aids on a 7 pt scale; a larger number is associated with better outcome
Measured: two weeks
Computerized Assisted Speech Perception Assessment (CASPA)
Speech recognition test; phoneme recognition score as percentage correct
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Aug 2021 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Why it stopped: We did not receive the equipment from our subcontractor in a time frame that would allow us to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by San Diego State 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated-measures crossover design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Carol L Mackersie, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728907
- Sponsor's protocol ID
- 2183099
- Status last verified
- Jun 2021
- First submitted
- 31 Oct 2018
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
- ClinicalTrials.gov ID
- NCT03728907
- Acronym / sponsor ID
- 2183099
- Conditions
- Hearing Loss
- Keywords
- hearing aid, self-fitting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not receive the equipment from our subcontractor in a time frame that would allow us to complete the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 2 Nov 2018 (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.
Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Repeated-measures crossover design
| Arm | Type | Receives |
|---|---|---|
| Audiologist-adjusted first | Active comparator | Device: Hearing aid fitting technique- audiologist or user-adjustedThis arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting. |
| User-adjusted first | Experimental | Device: Hearing aid fitting technique- audiologist or user-adjustedThis arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
- English speaking
Key exclusion criteria (2 listed)
- Score less than 21 on the MoCa (Montreal Cognitive Assessment)
- Evidence of conductive or retrocochlear pathology
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 technique- audiologist or user-adjustedSee information under 'arm' description | Device | Audiologist-adjusted first, User-adjusted first |
Primary outcome
Real-ear aided output
Time frame: two weeks
aided output (in dB SPL) measured across frequencies in the ears of the participants
2 secondary outcomes
Device Oriented Scale of Improvement (DOSO)
Time frame: two weeks
Computerized Assisted Speech Perception Assessment (CASPA)
Time frame: two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid fitting technique- audiologist or user-adjusted in people with Hearing Loss, run by San Diego State University.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 Jun 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Real-ear aided output (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2021.