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Behavioural Intervention

Speech-based hearing aid fitting for Central Auditory Processing Disorder (SBA Trial)

N/A

Waitlist Available

Led By Jonathan Venezia, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline (pre-intervention; v4) and at the end of the final week of the 6-week hearing aid intervention (v11). results will be reported through study completion, on average once per year (aligned with the rppr).

Awards & highlights

SBA Trial Summary

This trial aims to investigate the effectiveness of using a data-driven approach called speech-based audiometry (SBA) to optimize hearing aid gains for blast-exposed Veterans with functional hearing difficulties (FHDs

Who is the study for?

This trial is for blast-exposed Veterans who have trouble hearing in noisy places but have normal hearing tests. They should not already be using a low-gain hearing aid and must be able to complete speech recognition tasks and undergo neuroimaging.Check my eligibility

What is being tested?

The study compares two ways of fitting low-gain hearing aids: the usual method based on pure-tone audiograms, and a new data-driven approach using patient responses to speech in noise. It measures how well participants recognize speech with background noise and their brain activity during these tasks.See study design

What are the potential side effects?

Since this trial involves non-invasive procedures like fitting hearing aids and functional neuroimaging, side effects are minimal but may include discomfort from wearing the device or being in an imaging machine.

SBA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline (pre-intervention; v4) and at the end of the final week of the 6-week hearing aid intervention (v11). results will be reported through study completion, on average once per year (aligned with the rppr).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline (pre-intervention; v4) and at the end of the final week of the 6-week hearing aid intervention (v11). results will be reported through study completion, on average once per year (aligned with the rppr).

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline (pre-intervention; v4) and at the end of the final week of the 6-week hearing aid intervention (v11). results will be reported through study completion, on average once per year (aligned with the rppr). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Abbreviated Profile of Hearing Aid Benefit (APHAB)

Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks

Secondary outcome measures

Change in Digits in Noise Test (DIN) Score at Weekly Intervals from Baseline to 6 weeks

Other outcome measures

Change in fMRI Activation at 6 weeks

SBA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Speech-based hearing aid fittingExperimental Treatment1 Intervention

Half of the study participants receive a hearing aid with gain settings determined via speech-based audiometry. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.

Group II: Audiogram-based hearing aid fittingActive Control1 Intervention

Half of the study participants receive a hearing aid with gain settings determined by applying the NAL-NL2 prescriptive formula to the pure-tone audiogram. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,523 Total Patients Enrolled

1 Trials studying Central Auditory Processing Disorder

84 Patients Enrolled for Central Auditory Processing Disorder

University of California, San DiegoOTHER

1,120 Previous Clinical Trials

1,521,327 Total Patients Enrolled

NADI Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being actively enrolled in this trial?

"Information available on clinicaltrials.gov indicates that this particular trial is not currently in the recruitment phase. Although initially posted online on April 1, 2024, it was last modified on March 6, 2024. While this specific study has closed its patient enrollment process, there are alternative trials open for participant recruitment as of now."

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