Hearing Loss, SensorineuralNCT03666676
Hearing Study: Sensitivity to Features of Speech Sounds
A study testing Signal processing to improve intelligibility in people with Hearing Loss, Sensorineural, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Signal processing to improve intelligibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2020to 1 Aug 2024
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal hearing, mild or moderate symmetric sensorineural hearing loss.
Who cannot join
- Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).
- Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auditory Processing of Complex Sounds - Sensitivity to Chirps
The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.
Read the detailed description
The investigators will test listeners with normal hearing or with mild or moderate hearing loss. Tests will first focus on sensitivity to changes in fast changes in amplitude (loudness) or frequency (pitch) in sounds. Then the investigators will test the intelligibility of synthetic vowels and syllables in which these "chirps" are manipulated. Finally, the investigators will test intelligibility of words in noise while manipulating sounds in an effort to improve clarity.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Signal processing to improve intelligibility
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal processing to improve intelligibilityOther
Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
| Study group | Role | What they receive |
|---|---|---|
| Normal Hearing | Active comparator | Signal processing to improve intelligibility Receives: Other: Signal processing to improve intelligibility |
| Mild hearing loss | Active comparator | Signal processing to improve intelligibility Receives: Other: Signal processing to improve intelligibility |
| Moderate hearing loss | Active comparator | Signal processing to improve intelligibility Receives: Other: Signal processing to improve intelligibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure-tone Average Thresholds
Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears.
Measured: 6 months
F1 Discrimination Threshold
Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds.
Measured: 6 months
F2 Discrimination Threshold
Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start9 Jun 2020
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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 Loss, SensorineuralStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Laurel Carney, University of Rochester
- Investigators
- Laurel H Carney, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666676
- Sponsor's protocol ID
- 73346
- Other IDs
- R01DC001641
- Status last verified
- May 2025
- First submitted
- 8 Sep 2018
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carney LH, Cameron DA, Kinast KB, Feld CE, Schwarz DM, Leong UC, McDonough JM. Effects of sensorineural hearing loss on formant-frequency discrimination: Measurements and models. Hear Res. 2023 Aug;435:108788. doi: 10.1016/j.heares.2023.108788. Epub 2023 May 8.
PubMed 37224720
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Processing of Complex Sounds - Sensitivity to Chirps
- ClinicalTrials.gov ID
- NCT03666676
- Acronym / sponsor ID
- 73346
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.
Detailed description
The investigators will test listeners with normal hearing or with mild or moderate hearing loss. Tests will first focus on sensitivity to changes in fast changes in amplitude (loudness) or frequency (pitch) in sounds. Then the investigators will test the intelligibility of synthetic vowels and syllables in which these "chirps" are manipulated. Finally, the investigators will test intelligibility of words in noise while manipulating sounds in an effort to improve clarity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Hearing | Active comparator | Other: Signal processing to improve intelligibilitySignal processing to improve intelligibility |
| Mild hearing loss | Active comparator | Other: Signal processing to improve intelligibilitySignal processing to improve intelligibility |
| Moderate hearing loss | Active comparator | Other: Signal processing to improve intelligibilitySignal processing to improve intelligibility |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal hearing, mild or moderate symmetric sensorineural hearing loss.
Key exclusion criteria (2 listed)
- Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).
- Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).
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 |
|---|---|---|
| Signal processing to improve intelligibilitySignal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds. | Other | Mild hearing loss, Moderate hearing loss, Normal Hearing |
Primary outcome
Pure-tone Average Thresholds
Time frame: 6 months
Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears.
F1 Discrimination Threshold
Time frame: 6 months
Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds.
F2 Discrimination Threshold
Time frame: 6 month
Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37224720Carney LH, Cameron DA, Kinast KB, Feld CE, Schwarz DM, Leong UC, McDonough JM. Effects of sensorineural hearing loss on formant-frequency discrimination: Measurements and models. Hear Res. 2023 Aug;435:108788. doi: 10.1016/j.heares.2023.108788. Epub 2023 May 8.
- Individual participant dataSharing planned: No
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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.
Laurel H Carney, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signal processing to improve intelligibility in people with Hearing Loss, Sensorineural, run by University of Rochester 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 1 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: finished, as of the sponsor's last update on 29 May 2025. 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 29 May 2025). 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?
Pure-tone Average Thresholds (time frame: 6 months). The study lists 3 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 NCT03666676, 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 29 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.