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Speech Perception Training: Advanced Scoring and Feedback Methods

Primary Purpose

Hearing Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech Recognition Training
Sponsored by
SeeHear LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring lipreading speechreading, perceptual learning, adults with acquired hearing loss, multisensory speech processing, remote training system, speech recognition in noise, perceptual feedback during training

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • George Washington University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

No Intervention

Experimental

Experimental

Experimental

Arm Label

Aim 1, Sentence Training: Sentence Feedback

Aim 1, Sentence Training: Word Feedback

Aim 1, Sentence Training: Consonant Feedback

Aim 1, Sentence Training: No Training Control

Aim 2, Nonsense Word Training

Aim 3, Audiovisual Nonsense Word Training

Aim 3, Audiovisual Sentence Training

Arm Description

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.

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.

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.

Participants receive only the pre- and post-training tests.

Participants train to lipread nonsense words that name nonsense pictures. Participants receive pre- and post-training tests.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 2, 2021
Last Updated
February 14, 2023
Sponsor
SeeHear LLC
Collaborators
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT05012774
Brief Title
Speech Perception Training: Advanced Scoring and Feedback Methods
Official Title
Speech Perception Training: Advanced Scoring and Feedback Methods
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeeHear LLC
Collaborators
George Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aim 1, Sentence Training: Sentence Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 1, Sentence Training: Word Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 1, Sentence Training: Consonant Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 1, Sentence Training: No Training Control
Arm Type
No Intervention
Arm Description
Participants receive only the pre- and post-training tests.
Arm Title
Aim 2, Nonsense Word Training
Arm Type
Experimental
Arm Description
Participants train to lipread nonsense words that name nonsense pictures. Participants receive pre- and post-training tests.
Arm Title
Aim 3, Audiovisual Nonsense Word Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 3, Audiovisual Sentence Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Speech Recognition Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in words-correct scores across pre- and post-training sentence lipreading tests.
Description
Change in words-correct scores across pre- and post-training visual-only sentence tests with open-set responses.
Time Frame
up to 8 weeks
Title
Change in phonemes-correct scores across pre- and post-training sentence lipreading tests.
Description
Change in phonemes-correct scores across pre- and post-training visual-only sentence tests with open-set responses.
Time Frame
up to 8 weeks
Title
Change in consonant-identification scores across pre- and post-training word lipreading tests.
Description
Change in consonants-correct scores across pre- and post-training for visual-only tests using isolated nonsense words and closed-set responses.
Time Frame
up to 8 weeks
Title
Change in word-correct scores across pre- and post-training word lipreading tests.
Description
Change in words-correct scores across pre- and post-training visual-only isolated real word tests with open-set response.
Time Frame
up to 8 weeks
Title
Change in phonemes-correct scores across pre- and post-training word lipreading tests.
Description
Change in phonemes-correct scores across pre- and post-training visual-only isolated real word tests with open-set response.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in words-correct scores across pre- and post-training audiovisual sentence tests.
Description
Change in words-correct scores across pre- and post-training audiovisual-in-noise sentence identification tests with open-set response.
Time Frame
up to 8 weeks
Title
Change in phonemes-correct scores across pre- and post-training audiovisual sentence tests.
Description
Change in phonemes-correct scores across pre- and post-training audiovisual-in-noise sentence identification tests with open-set response.
Time Frame
up to 8 weeks
Title
Change in word-correct scores across pre- and post-training for audiovisual-in-noise word tests.
Description
Change in word-correct scores across pre- and post-training audiovisual-in-noise isolated real word tests with open-set response.
Time Frame
up to 8 weeks
Title
Change in phoneme-recognition scores across pre- and post-training audiovisual-in-noise word tests.
Description
Change in phoneme-recognition scores across pre- and post-training audiovisual-in-noise isolated real word tests with open-set response.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne E Bernstein, Ph.D.
Organizational Affiliation
George Washington University
Official's Role
Study Director
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
Virginia
ZIP/Postal Code
20052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available after they have been described in publications by the authors.
IPD Sharing Access Criteria
The data will be transferred via the Open Science Framework.
IPD Sharing URL
http://osf.org

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Speech Perception Training: Advanced Scoring and Feedback Methods

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