Hearing Aids for Central Auditory Processing Disorder (SBA Trial)

N/A

Recruiting

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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abbreviated Profile of Hearing Aid Benefit (APHAB)

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

Secondary study objectives

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

Other study objectives

Change in fMRI Activation at 6 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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