- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05012774
Speech Perception Training: Advanced Scoring and Feedback Methods
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Washington, Virginia, United States, 20052
- George Washington University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Internet too slow for streaming
- History of brain trauma or learning disability
- Poor (corrected) vision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aim 1, Sentence Training: Sentence Feedback
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. |
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.
|
Experimental: Aim 1, Sentence Training: Word Feedback
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. |
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.
|
Experimental: Aim 1, Sentence Training: Consonant Feedback
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. |
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.
|
No Intervention: Aim 1, Sentence Training: No Training Control
Participants receive only the pre- and post-training tests.
|
|
Experimental: Aim 2, Nonsense Word Training
Participants train to lipread nonsense words that name nonsense pictures.
Participants receive pre- and post-training tests.
|
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.
|
Experimental: Aim 3, Audiovisual Nonsense Word Training
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. |
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.
|
Experimental: Aim 3, Audiovisual Sentence Training
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 8 weeks
|
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.
|
up to 8 weeks
|
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.
|
up to 8 weeks
|
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.
|
up to 8 weeks
|
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.
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in words-correct scores across pre- and post-training audiovisual sentence tests.
Time Frame: up to 8 weeks
|
Change in words-correct scores across pre- and post-training audiovisual-in-noise sentence identification tests with open-set response.
|
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 phonemes-correct scores across pre- and post-training audiovisual-in-noise sentence identification tests with open-set response.
|
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 word-correct scores across pre- and post-training audiovisual-in-noise isolated real word tests with open-set response.
|
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
|
Change in phoneme-recognition scores across pre- and post-training audiovisual-in-noise isolated real word tests with open-set response.
|
up to 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC015418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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