Hearing LossNCT05012774
Speech Perception Training: Advanced Scoring and Feedback Methods
A study testing Speech Recognition Training in people with Hearing Loss, run by SeeHear LLC at 1 site in United States.
Trial summary
The purpose of the study is to assess training of visual speech (lipreading) and audiovisual (lipreading plus auditory) speech as a rehabilitation strategy for hearing loss in adults. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Speech Recognition Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 31 Aug 2023
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have Mild to severe hearing loss
- Native speaker of American English
- Access to computer and the ability to use it for the testing, training, and teleconferencing
- computer display >= 10 inches diagonal
Who cannot join
- Internet too slow for streaming
- History of brain trauma or learning disability
- Poor (corrected) vision
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington, Virginia, 20052
About this study
The purpose of the study is to assess training of visual speech (lipreading) and audiovisual (lipreading plus auditory) speech as a rehabilitation strategy for hearing loss in adults.
Read the detailed description
It is hypothesized that training that improves lipreading in older adults can carry over to untrained lipreading materials and to audiovisual speech recognition in noise. Participants receive pre- and post-training tests of speech recognition with visual-only, auditory-only, and audiovisual spoken sentences and isolated words. During pre- and post-training tests, they carry out forced choice identification of lipread consonants. Participants who are assigned to a training arm train on lipreading isolated sentences (Aim 1) or on learning via lipreading sets of isolated nonsense words (Aim 2). Depending on the outcomes of Aims 1 and 2, in Aim 3, new participants receive audiovisual training with conditions from Aims 1 and 2.
- Conditions
- Hearing Loss
- Being tested
- Speech Recognition Training
- Keywords
- lipreading speechreading, perceptual learning, adults with acquired hearing loss, multisensory speech processing, remote training system, speech recognition in noise, perceptual feedback during training
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Recognition TrainingBehavioural
Training for each training arm takes place over 10 sessions carried out at home. on the participant's own computer without experimenter direct supervision. Pre- and post-training tests are carried out under experimenter supervision.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1, Sentence Training: Sentence Feedback | Experimental | In Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading.
This arm gives printed whole sentence feedback following an attempt to lipread each sentence.
Participants receive pre- and post-training tests. Receives: Behavioral: Speech Recognition Training |
| Aim 1, Sentence Training: Word Feedback | Experimental | In Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading.
This arm gives printed whole word feedback following an attempt to lipread each sentence. Word feedback is for correct words and words that are perceptually similar but incorrect responses.
Participants receive pre- and post-training tests. Receives: Behavioral: Speech Recognition Training |
| Aim 1, Sentence Training: Consonant Feedback | Experimental | In Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading.
This arm gives printed consonant word feedback following an attempt to lipread each sentence. Word feedback is for correct words, but only the consonants are given as feedback for words that are perceptually similar but incorrect responses.
Participants receive pre- and post-training tests. Receives: Behavioral: Speech Recognition Training |
| Aim 1, Sentence Training: No Training Control | No intervention | Participants receive only the pre- and post-training tests. |
| Aim 2, Nonsense Word Training | Experimental | Participants train to lipread nonsense words that name nonsense pictures. Participants receive pre- and post-training tests. Receives: Behavioral: Speech Recognition Training |
| Aim 3, Audiovisual Nonsense Word Training | Experimental | Participants train to recognize audiovisual spoken nonsense words that name nonsense pictures and are presented in speech-shaped noise. The paradigm is the same as in Aim 2.
Participants receive pre- and post-training tests. Receives: Behavioral: Speech Recognition Training |
| Aim 3, Audiovisual Sentence Training | Experimental | Participants receive the same training paradigm from Aim 1 with the most effective feedback type from Aim 1. But the sentences are audiovisual and in speech-shaped noise.
Participants receive pre- and post-training tests. Receives: Behavioral: Speech Recognition Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in words-correct scores across pre- and post-training sentence lipreading tests.
Change in words-correct scores across pre- and post-training visual-only sentence tests with open-set responses.
Measured: up to 8 weeks
Change in phonemes-correct scores across pre- and post-training sentence lipreading tests.
Change in phonemes-correct scores across pre- and post-training visual-only sentence tests with open-set responses.
Measured: up to 8 weeks
Change in consonant-identification scores across pre- and post-training word lipreading tests.
Change in consonants-correct scores across pre- and post-training for visual-only tests using isolated nonsense words and closed-set responses.
Measured: up to 8 weeks
Change in word-correct scores across pre- and post-training word lipreading tests.
Change in words-correct scores across pre- and post-training visual-only isolated real word tests with open-set response.
Measured: up to 8 weeks
Change in phonemes-correct scores across pre- and post-training word lipreading tests.
Change in phonemes-correct scores across pre- and post-training visual-only isolated real word tests with open-set response.
Measured: up to 8 weeks
Secondary outcomes (4)
Change in words-correct scores across pre- and post-training audiovisual sentence tests.
Change in words-correct scores across pre- and post-training audiovisual-in-noise sentence identification tests with open-set response.
Measured: up to 8 weeks
Change in phonemes-correct scores across pre- and post-training audiovisual sentence tests.
Change in phonemes-correct scores across pre- and post-training audiovisual-in-noise sentence identification tests with open-set response.
Measured: up to 8 weeks
Change in word-correct scores across pre- and post-training for audiovisual-in-noise word tests.
Change in word-correct scores across pre- and post-training audiovisual-in-noise isolated real word tests with open-set response.
Measured: up to 8 weeks
Change in phoneme-recognition scores across pre- and post-training audiovisual-in-noise word tests.
Change in phoneme-recognition scores across pre- and post-training audiovisual-in-noise isolated real word tests with open-set response.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start14 Jul 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2023 (estimated)
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.
- 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
- In Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading. The three types are consonant-level, word-level, or sentence-level feedback. A no-training wait-list control is included. In Aim 2, novel word training, the intervention has one arm in which novel word learning via lipreading the words is supported by allowing the participants to read the consonants in the novel words before lipreading them. In Aim 3, the most effective feedback with sentence training will be compared with novel word training using training stimuli that are audiovisual speech in speech-shaped noise. The interventions are all delivered individually via the web. Finally, all pre- and post-training results will be compared across groups including the wait-list controls.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeeHear LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- George Washington University
- Responsible party
- Sponsor
- Investigators
- Lynne E Bernstein, Ph.D., Study director, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012774
- Sponsor's protocol ID
- DC015418
- Status last verified
- Feb 2023
- First submitted
- 2 Aug 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with other researchers following appropriate agreements. Personally-identifiable data will never be shared with individuals outside the research team, except as required by Law, NIH, or Geourge Washington University.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Perception Training: Advanced Scoring and Feedback Methods
- ClinicalTrials.gov ID
- NCT05012774
- Acronym / sponsor ID
- DC015418
- Conditions
- Hearing Loss
- Keywords
- lipreading speechreading, perceptual learning, adults with acquired hearing loss, multisensory speech processing, remote training system, speech recognition in noise, perceptual feedback during training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (actual)
- Lead sponsor
- SeeHear LLCIndustry (pharma, biotech, devices)
- Collaborators
- George Washington University
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 19 Aug 2021 (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 purpose of the study is to assess training of visual speech (lipreading) and audiovisual (lipreading plus auditory) speech as a rehabilitation strategy for hearing loss in adults.
Detailed description
It is hypothesized that training that improves lipreading in older adults can carry over to untrained lipreading materials and to audiovisual speech recognition in noise. Participants receive pre- and post-training tests of speech recognition with visual-only, auditory-only, and audiovisual spoken sentences and isolated words. During pre- and post-training tests, they carry out forced choice identification of lipread consonants. Participants who are assigned to a training arm train on lipreading isolated sentences (Aim 1) or on learning via lipreading sets of isolated nonsense words (Aim 2). Depending on the outcomes of Aims 1 and 2, in Aim 3, new participants receive audiovisual training with conditions from Aims 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- In Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading. The three types are consonant-level, word-level, or sentence-level feedback. A no-training wait-list control is included. In Aim 2, novel word training, the intervention has one arm in which novel word learning via lipreading the words is supported by allowing the participants to read the consonants in the novel words before lipreading them. In Aim 3, the most effective feedback with sentence training will be compared with novel word training using training stimuli that are audiovisual speech in speech-shaped noise. The interventions are all delivered individually via the web. Finally, all pre- and post-training results will be compared across groups including the wait-list controls.
| Arm | Type | Receives |
|---|---|---|
| Aim 1, Sentence Training: Sentence Feedback | Experimental | Behavioral: Speech Recognition TrainingIn Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading. This arm gives printed whole sentence feedback following an attempt to lipread each sentence. Participants receive pre- and post-training tests. |
| Aim 1, Sentence Training: Word Feedback | Experimental | Behavioral: Speech Recognition TrainingIn Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading. This arm gives printed whole word feedback following an attempt to lipread each sentence. Word feedback is for correct words and words that are perceptually similar but incorrect responses. Participants receive pre- and post-training tests. |
| Aim 1, Sentence Training: Consonant Feedback | Experimental | Behavioral: Speech Recognition TrainingIn Aim 1, which is sentence lipreading training, the intervention compares the provision of three different types of feedback for lipreading. This arm gives printed consonant word feedback following an attempt to lipread each sentence. Word feedback is for correct words, but only the consonants are given as feedback for words that are perceptually similar but incorrect responses. Participants receive pre- and post-training tests. |
| Aim 1, Sentence Training: No Training Control | No intervention | –Participants receive only the pre- and post-training tests. |
| Aim 2, Nonsense Word Training | Experimental | Behavioral: Speech Recognition TrainingParticipants train to lipread nonsense words that name nonsense pictures. Participants receive pre- and post-training tests. |
| Aim 3, Audiovisual Nonsense Word Training | Experimental | Behavioral: Speech Recognition TrainingParticipants train to recognize audiovisual spoken nonsense words that name nonsense pictures and are presented in speech-shaped noise. The paradigm is the same as in Aim 2. Participants receive pre- and post-training tests. |
| Aim 3, Audiovisual Sentence Training | Experimental | Behavioral: Speech Recognition TrainingParticipants receive the same training paradigm from Aim 1 with the most effective feedback type from Aim 1. But the sentences are audiovisual and in speech-shaped noise. Participants receive pre- and post-training tests. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have Mild to severe hearing loss
- Native speaker of American English
- Access to computer and the ability to use it for the testing, training, and teleconferencing
- computer display >= 10 inches diagonal
Key exclusion criteria (3 listed)
- Internet too slow for streaming
- History of brain trauma or learning disability
- Poor (corrected) vision
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 |
|---|---|---|
| Speech Recognition TrainingTraining for each training arm takes place over 10 sessions carried out at home. on the participant's own computer without experimenter direct supervision. Pre- and post-training tests are carried out under experimenter supervision. | Behavioural | Aim 1, Sentence Training: Consonant Feedback, Aim 1, Sentence Training: Sentence Feedback, Aim 1, Sentence Training: Word Feedback, Aim 2, Nonsense Word Training, Aim 3, Audiovisual Nonsense Word Training, Aim 3, Audiovisual Sentence Training |
Primary outcome
Change in words-correct scores across pre- and post-training sentence lipreading tests.
Time frame: up to 8 weeks
Change in words-correct scores across pre- and post-training visual-only sentence tests with open-set responses.
Change in phonemes-correct scores across pre- and post-training sentence lipreading tests.
Time frame: up to 8 weeks
Change in phonemes-correct scores across pre- and post-training visual-only sentence tests with open-set responses.
Change in consonant-identification scores across pre- and post-training word lipreading tests.
Time frame: up to 8 weeks
Change in consonants-correct scores across pre- and post-training for visual-only tests using isolated nonsense words and closed-set responses.
Change in word-correct scores across pre- and post-training word lipreading tests.
Time frame: up to 8 weeks
Change in words-correct scores across pre- and post-training visual-only isolated real word tests with open-set response.
Change in phonemes-correct scores across pre- and post-training word lipreading tests.
Time frame: up to 8 weeks
Change in phonemes-correct scores across pre- and post-training visual-only isolated real word tests with open-set response.
4 secondary outcomes
Change in words-correct scores across pre- and post-training audiovisual sentence tests.
Time frame: up to 8 weeks
Change in phonemes-correct scores across pre- and post-training audiovisual sentence tests.
Time frame: up to 8 weeks
Change in word-correct scores across pre- and post-training for audiovisual-in-noise word tests.
Time frame: up to 8 weeks
Change in phoneme-recognition scores across pre- and post-training audiovisual-in-noise word tests.
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other researchers following appropriate agreements. Personally-identifiable data will never be shared with individuals outside the research team, except as required by Law, NIH, or Geourge Washington University.
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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.
Lynne E Bernstein, Ph.D. study director
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Recognition Training in people with Hearing Loss, run by SeeHear LLC 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 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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?
Results are not available in the source record.
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?
Change in words-correct scores across pre- and post-training sentence lipreading tests. (time frame: up to 8 weeks). The study lists 5 primary outcomes in all. 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 15 Feb 2023.