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Clinical Trials/NCT06738030
NCT06738030
Not Yet Recruiting
N/A

Transcranial Stimulation Combined With Auditory Training

Boston University Charles River Campus1 site in 1 country94 target enrollmentJanuary 20, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Difficulties Understanding Speech in Noise
Sponsor
Boston University Charles River Campus
Enrollment
94
Locations
1
Primary Endpoint
Speech-on-speech intelligibility percent correct
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to learn if non-invasive brain stimulation (called transcranial stimulation) can enhance the benefits from auditory training in people who struggle to understand one talker when many people are talking at the same time. The main questions it aims to answer are:

  • Does transcranial stimulation improve speech-on-speech understanding in people who struggle with this task?
  • Does transcranial stimulation enhance the benefits of a commercially available auditory training program?

Researchers will compare transcranial stimulation to sham stimulation (no stimulation is applied during the listening task).

Participants will:

  • Receive login information to an online auditory training program to complete at home over 2 weeks
  • Visit the laboratory 4 times to receive transcranial stimulation while listening to speech-on-speech: once before at-home training, two times during the at-home training period, and once after at-home training has ended
Registry
clinicaltrials.gov
Start Date
January 20, 2025
End Date
August 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 50 years of age or older
  • Audiometric thresholds that do not exceed 90 dB HL at any frequency from 250-6000 Hz
  • Able to provide informed consent and understand experimental instructions
  • Able to read print on a computer screen
  • Difficulty with speech-on-speech understanding
  • Access to computer or mobile phone with access to internet that can play sound (for the at-home training)

Exclusion Criteria

  • Non-native speakers of English
  • History of skull fracture, scalp tissue damage, metallic implants around the head, seizures, neurological disorders, or traumatic brain injury, current or suspected pregnancy

Outcomes

Primary Outcomes

Speech-on-speech intelligibility percent correct

Time Frame: From enrollment to the end of participation at 6 weeks

Percent correct score on the speech-on-speech task assessed in the lab

Pupillometry measured listening effort

Time Frame: From enrollment to the end of participation at 6 weeks

The peak pupil dilation subtracted from pre-trial baseline pupil dilation, averaged across trials in a block, assessed in the lab

QuickSIN SNR Loss

Time Frame: Days 1, 6, and 14 of the two-week auditory training

A speech-in-noise test assessed as part of the at-home auditory training program

Hearing Handicap Inventory

Time Frame: Days 1 and 14 of the two-week auditory training program

A listening effort questionnaire given as part of the at-home auditory training program

Study Sites (1)

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