NCT05012774

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

August 2, 2021

Last Update Submit

February 14, 2023

Conditions

Keywords

lipreading speechreadingperceptual learningadults with acquired hearing lossmultisensory speech processingremote training systemspeech recognition in noiseperceptual feedback during training

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Change in words-correct scores across pre- and post-training audiovisual sentence tests.

    up to 8 weeks

  • Change in phonemes-correct scores across pre- and post-training audiovisual sentence tests.

    up to 8 weeks

  • Change in word-correct scores across pre- and post-training for audiovisual-in-noise word tests.

    up to 8 weeks

  • Change in phoneme-recognition scores across pre- and post-training audiovisual-in-noise word tests.

    up to 8 weeks

Study Arms (7)

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.

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.

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.

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.

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.

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.

Behavioral: Speech Recognition Training

Interventions

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.

Aim 1, Sentence Training: Consonant FeedbackAim 1, Sentence Training: Sentence FeedbackAim 1, Sentence Training: Word FeedbackAim 2, Nonsense Word TrainingAim 3, Audiovisual Nonsense Word TrainingAim 3, Audiovisual Sentence Training

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Internet too slow for streaming
  • History of brain trauma or learning disability
  • Poor (corrected) vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University

Washington, Virginia, 20052, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lynne E Bernstein, Ph.D.

    George Washington University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 19, 2021

Study Start

July 14, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available after they have been described in publications by the authors.
Access Criteria
The data will be transferred via the Open Science Framework.
More information

Locations