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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05012774
Other study ID # DC015418
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 14, 2021
Est. completion date August 31, 2023

Study information

Verified date February 2023
Source SeeHear LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 138
Est. completion date August 31, 2023
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Speech Recognition Training
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.

Locations

Country Name City State
United States George Washington University Washington Virginia

Sponsors (2)

Lead Sponsor Collaborator
SeeHear LLC George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 8 weeks
Primary 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. up to 8 weeks
Primary 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. up to 8 weeks
Primary 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. up to 8 weeks
Primary 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. up to 8 weeks
Secondary 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. up to 8 weeks
Secondary 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. up to 8 weeks
Secondary 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. up to 8 weeks
Secondary 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. up to 8 weeks
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