Hearing Loss, SensorineuralNCT01867515
Spectral Dynamics and Speech Understanding by Hearing Impaired People
A study testing Acoustic distortion of speech in people with Hearing Loss, Sensorineural, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this program of research is to understand the perception of the dynamic spectral properties of speech by hearing-impaired listeners, with the long-term goal of improving speech understanding by these individuals in adverse listening conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Acoustic distortion of speech
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
- or, individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
Who cannot join
- a conductive hearing impairment or other otological pathology
- hearing thresholds greater than 70 dB HL at any frequencies of 4000 Hz or below or pure-tone averages (averaged across 500, 1000, and 2000 Hz) of greater than 65 dB HL
- bilateral differences greater than 20 dB at any frequency below 4000 Hz
- an inability to complete the experimental tasks
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
The purpose of this program of research is to understand the perception of the dynamic spectral properties of speech by hearing-impaired listeners, with the long-term goal of improving speech understanding by these individuals in adverse listening conditions. The proposed research compares the performance of normally-hearing and hearing-impaired listeners on measures of speech understanding in the presence of different types of signal distortion and speech understanding of signals with enhanced spectral dynamics. A computational model based on the amount of potential information available in speech will be used to quantify differences in speech intelligibility due to hearing status and stimulus characteristics.
Read the detailed description
This is a behavioral study of human auditory perception. Each experiment in this study involves prospective data collection from three types of listeners. The experimental listeners will be people with sensorineural hearing loss and the control listeners will either be subjects with normal hearing or normal-hearing listeners for whom hearing loss will be simulated through the use of a spectrally-shaped broadband noise. The tasks of the subjects in this study involve either listening to synthesized sounds over earphones while seated comfortably in a sound-treated booth, and making responses indicating the subject's auditory perception of these sounds by touching specific areas on a touch-screen terminal; or, listening to recorded, acoustically modified syllables, words, or sentences over earphones and making responses indicating the subject's identification.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Acoustic distortion of speech
- Keywords
- Hearing, Hearing Loss, sensorineural, Speech Perception
- 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.
Acoustic distortion of speechOther
| Study group | Role | What they receive |
|---|---|---|
| Younger normally-hearing listeners | Active comparator | Participants with auditory thresholds within the normal limits.
* age between 18 and 35
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech Receives: Other: Acoustic distortion of speech |
| Hearing-impaired listeners | Active comparator | individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
* age 18 to 65 Acoustic distortion of speech Receives: Other: Acoustic distortion of speech |
| Older normally-hearing listeners | Active comparator | Participants with auditory thresholds within the normal limits.
* age between 36 and 65
* individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech Receives: Other: Acoustic distortion of speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Correct Words Identified
The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.
Measured: average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2016
- Study completionSep 2016
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.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michelle R Molis, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867515
- Sponsor's protocol ID
- C1020-R
- Other IDs
- 5I01RX001020-03
- Status last verified
- Apr 2018
- First submitted
- 20 May 2013
- Last updated
- 26 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Dynamics and Speech Understanding by Hearing Impaired People
- ClinicalTrials.gov ID
- NCT01867515
- Acronym / sponsor ID
- C1020-R
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Hearing, Hearing Loss, sensorineural, Speech Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 26 Apr 2018
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 program of research is to understand the perception of the dynamic spectral properties of speech by hearing-impaired listeners, with the long-term goal of improving speech understanding by these individuals in adverse listening conditions. The proposed research compares the performance of normally-hearing and hearing-impaired listeners on measures of speech understanding in the presence of different types of signal distortion and speech understanding of signals with enhanced spectral dynamics. A computational model based on the amount of potential information available in speech will be used to quantify differences in speech intelligibility due to hearing status and stimulus characteristics.
Detailed description
This is a behavioral study of human auditory perception. Each experiment in this study involves prospective data collection from three types of listeners. The experimental listeners will be people with sensorineural hearing loss and the control listeners will either be subjects with normal hearing or normal-hearing listeners for whom hearing loss will be simulated through the use of a spectrally-shaped broadband noise. The tasks of the subjects in this study involve either listening to synthesized sounds over earphones while seated comfortably in a sound-treated booth, and making responses indicating the subject's auditory perception of these sounds by touching specific areas on a touch-screen terminal; or, listening to recorded, acoustically modified syllables, words, or sentences over earphones and making responses indicating the subject's identification.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Younger normally-hearing listeners | Active comparator | Other: Acoustic distortion of speechParticipants with auditory thresholds within the normal limits. * age between 18 and 35 * individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech |
| Hearing-impaired listeners | Active comparator | Other: Acoustic distortion of speechindividuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below * age 18 to 65 Acoustic distortion of speech |
| Older normally-hearing listeners | Active comparator | Other: Acoustic distortion of speechParticipants with auditory thresholds within the normal limits. * age between 36 and 65 * individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
- or, individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
Key exclusion criteria (4 listed)
- a conductive hearing impairment or other otological pathology
- hearing thresholds greater than 70 dB HL at any frequencies of 4000 Hz or below or pure-tone averages (averaged across 500, 1000, and 2000 Hz) of greater than 65 dB HL
- bilateral differences greater than 20 dB at any frequency below 4000 Hz
- an inability to complete the experimental tasks
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 |
|---|---|---|
| Acoustic distortion of speech | Other | Hearing-impaired listeners, Older normally-hearing listeners, Younger normally-hearing listeners |
Primary outcome
Percent Correct Words Identified
Time frame: average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Michelle R Molis, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic distortion of speech in people with Hearing Loss, Sensorineural, run by VA Office of Research and Development 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 2 inclusion and 4 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 26 Apr 2018. 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 26 Apr 2018). 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?
Percent Correct Words Identified (time frame: average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart). 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 26 Apr 2018.