Speech Perception Training: Advanced Scoring and Feedback Methods

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Speech Recognition Training

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

No Intervention

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

NCT ID

NCT05012774

First Posted

August 2, 2021

Last Updated

February 14, 2023

Sponsor

SeeHear LLC

Collaborators

George Washington University

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

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

Hearing Loss

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial