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Neuroprotectant

ACEMg for Hearing Loss and Tinnitus (OTISRWD Trial)

N/A

Recruiting

Research Sponsored by Keep Hearing, Inc.

Eligibility Criteria Checklist

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

Must have

Tinnitus self-reported at the baseline survey

Be older than 18 years old

Must not have

Previous use of ACEMg (Soundbites)

No tinnitus self-reported at the baseline survey

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time point zero; 12 and 24 weeks.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effects of ACEMg neuroprotectant biomedicine, taken as Soundbites softgel capsules, on auditory function and tinnitus symptoms. The study will analyze real

Who is the study for?

This trial is for adults with sensorineural hearing loss (SNHL) or tinnitus. Participants will take ACEMg softgel capsules daily and must be able to complete baseline assessments, as well as follow-up evaluations at approximately 12 and 24 weeks.

What is being tested?

The study tests whether ACEMg (Soundbites) can preserve or improve hearing in individuals with SNHL and if it can reduce tinnitus symptoms. It's a secondary analysis of real-world data from a previous two-year study, now focusing on results within six months.

What are the potential side effects?

The description does not specify side effects; however, since ACEMg is already available as Soundbites softgel capsules, typical supplement-related side effects may include digestive discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have reported experiencing ringing in my ears.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used ACEMg (Soundbites) before.

Select...

I do not have tinnitus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time point zero; 12 and 24 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time point zero; 12 and 24 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time point zero; 12 and 24 weeks. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Subjective measure of preservation or improvement of inner ear auditory function

Tinnitus symptom relief

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: At-homeExperimental Treatment1 Intervention

Subjective auditory function assessments with the hearWHO app. Tinnitus survey. Participants take ACEMg softgel capsules daily, self-administered orally.

0 / 3Eligibility criteria met