NCT04921267

Brief Summary

Human listeners will hear speech masked by single-talker speech before and after auditory training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
1 year until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

March 11, 2020

Last Update Submit

June 1, 2021

Conditions

Training Group

Outcome Measures

Primary Outcomes (4)

  • pretest EEG alpha power

    power in the alpha-band

    one day before training

  • posttest EEG alpha power

    power in the alpha-band

    one day after training

  • pretest accuracy

    proportion correct for identifying speech

    one day before training

  • posttest accuracy

    proportion correct for identifying speech

    one day after training

Study Arms (2)

trained group

EXPERIMENTAL

group receives training with sounds that correspond to simulated hearing protection

Behavioral: training

Control

NO INTERVENTION

group receives no training

Interventions

trainingBEHAVIORAL

training with filtered speech

trained group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal hearing

You may not qualify if:

  • hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas State University

Manhattan, Kansas, 66506, United States

Location

Study Officials

  • Matthew Wisniewski, PhD

    Kansas State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant doesn't know what condition they are in.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 2 groups. One group is trained to listening through simulated hearing protection. The other receives no such training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2020

First Posted

June 10, 2021

Study Start

October 10, 2019

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)