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Neuroprotectant

At-home for Sensorineural Hearing Loss (ACEMgRWD Trial)

N/A
Waitlist Available
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, or * Hearing loss assessed at the baseline test
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time point zero; 12 and 24 weeks.
Awards & highlights

Summary

This study is a secondary analysis of real-world data from 24-week tests of the ACEMg neuroprotectant biomedicine available as Soundbites softgel capsules. The study aims to validate findings from the previous two-year real-world study demonstrating ACEMg (Soundbites) preserved or improved auditory function (hearing) for 75.3% of participants who used it daily, with most improvement occurring within six months. Additionally, this study aims to assess the potential of ACEMg to relieve tinnitus symptoms in people with tinnitus. SNHL and tinnitus are related but tinnitus relief was not measured in the previous two-year study. The study aims to answer two questions. First, does the real-world data demonstrate that hearing loss is stabilized or improved at the end of the test among participants with sensorineural hearing loss (SNHL or inner ear hearing loss) at the beginning? Second, do participants who self-report tinnitus symptoms at the start of their test report reduced symptoms at the end? Participants must be eighteen years of age and older. The test starts with a baseline hearing assessment. Participants with tinnitus complete a baseline tinnitus survey. Then, each participant takes ACEMg softgel capsules daily, repeating the hearing assessment and the tinnitus survey after about 12 and 24 weeks. Assessment scores at the beginning of the study will be compared with scores at the end.

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

Timeline

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
Objective measure of preservation or improvement of inner ear auditory function
Subjective measure of preservation or improvement of inner ear auditory function
Tinnitus symptom relief

Trial Design

2Treatment groups
Experimental Treatment
Active Control
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.
Group II: ClinicalActive Control1 Intervention
Objective auditory function assessments with OAE examinations. Tinnitus survey. Participants take ACEMg softgel capsules daily, self-administered orally.

Find a Location

Who is running the clinical trial?

Keep Hearing, Inc.Lead Sponsor
Barry Seifer, MFAStudy DirectorKeep Hearing, Inc. 501c3
~1333 spots leftby Aug 2026