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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.
Full description
Introduction
ACEMg, developed at the University of Michigan Medical School, is designed to block the initiating biochemical events in the organ of Corti within the inner ear that lead to sensorineural hearing loss (SNHL).
The ACEMg formula is classified as Generally Regarded as Safe (GRAS) by the U.S. Pharmacopeia and regulated as a dietary supplement under FDA DSHEA law. The ACEMg patents are licensed to Soundbites Public Benefit Corporation (PBC), which produces an updated and improved oral softgel capsule dose format of ACEMg for adults, and an oral twist-off softgel capsule format for children, available to the general public without a prescription under the Soundbites trademark.
Background
The 2021-2023 ACEMg (Soundbites) Real-world Evidence Study (N=190) used de-identified real-world data (RWD) from routine annual otoacoustic emissions (OAE) examinations collected among adult patients of one audiology practice over many years before ACEMg became available. OAE examinations produce objective measures of inner ear auditory function.
The control dataset (N=97) represented the current standard of care for hearing, which is to say no treatment. Retrospective OAE RWD from the no-treatment group was analyzed and compared to RWD from a treatment group of patients (N=93) who also had at least two years of annual retrospective OAE examinations and began taking ACEMg immediately following their third annual OAE examination, thus enabling objective measurement of the potential impacts on auditory function from daily oral self-administration of ACEMg.
The study yielded statistically significant clinical data demonstrating that ACEMg effectively preserved and improved auditory function, thereby mitigating SNHL, demonstrating that ACEMg preserved or improved inner ear auditory function for 75.2% (N=70) of those in the treatment group (N=93), with most improvement occurring within the first six months of daily use.
The article reporting results from the study is available on the Open Science Framework (OSF) preprint server at https://osf.io/preprints/osf/uw7tq.
Study administrators concluded that the clinical data justify a larger study, especially considering the inherent safety of ACEMg and its availability in an inexpensive, convenient oral dose form, perhaps leading to considering ACEMg as an effective, accessible method of addressing the global challenge of hearing loss.
This study
Participants commit to testing ACEMg as Soundbites softgel capsules for about 6 months. The test starts with a baseline hearing assessment and tinnitus survey for participants reporting tinnitus symptoms. Then, each participant begins taking Soundbites daily, repeating the hearing assessment and tinnitus survey after about 12 and 24 weeks.
ACEMg and tinnitus
ACEMg was not designed to address tinnitus. Nevertheless, since ACEMg was offered as Soundbites softgels in 2017, reports from customers with tinnitus and from audiologists treating patients with tinnitus indicate that ongoing daily use of Soundbites reduces tinnitus symptoms for some.
An effective cure for tinnitus does not yet exist, as our understanding of tinnitus pathophysiology is still evolving. There appear to be multiple neurophysiological mechanisms involved in the production of tinnitus symptoms. A few models, notably the stochastic resonance model, point to a feedback function in the inner ear that increases metabolic stress and cochlear metabolic load, resulting in cochlear damage believed to be an initial step in tinnitus (Krauss & Schilling, 2016).
Objective
The study aims to validate findings from the two-year study that ACEMg stabilizes or improves auditory function in those with SNHL, and assess the potential impact of ACEMg on tinnitus symptoms.
Who can participate?
The study has two arms. Individuals eighteen years or older may participate at home or with a Soundbites-certified clinical audiologist. Individuals younger than eighteen years, those who do not have hearing loss or tinnitus, and those who have previously taken Soundbites are excluded from participating.
Hearing and tinnitus measures
At-home participants test their hearing with the hearWHO digits-in-hearing app developed for the World Health Organization until remote OAE test technology becomes available.
Clinical participants receive otoacoustic emissions (OAE) examinations. All participants reporting tinnitus symptoms at the start of the test complete the tinnitus survey designed for this study, which assesses the impact of tinnitus symptoms on daily activities.
Study agent
All participants test ACEMg formulated as Soundbites softgel capsules for adults.
Method
All participants start the test by completing a baseline hearing test, either an OAE examination or the hearWHO test. All participants with tinnitus complete the tinnitus survey. All participants begin taking Soundbites daily, repeating the hearing and tinnitus assessments about 12 weeks and 24 weeks post-baseline.
Data collection
All participant data is private. Data is entered in a secure online environment, and stored on the Open Science Framework online data store. Collected data is limited to birth date, gender, assessment dates, and assessment scores.
Each participant chooses whether to submit their de-identified data for analysis and reporting after their 24-week test is complete.
All data is shared for secondary analysis and reporting under a data-sharing agreement with the study sponsor, the Keep Hearing nonprofit.
Keep Hearing will hold the IRB allowances required to analyze de-identified secondary data.
Data analysis will be shared with each participant. Aggregated data analyses will be reported to the public in publicly available manuscripts submitted for peer review.
Costs
Participation in the study is free for at-home and clinical participants. Soundbites Public Benefit Corporation donates the Soundbites softgel capsules. Soundbites-certified audiologists donate their services conducting OAE examinations.
Enrollment
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Interventional model
Masking
2,000 participants in 2 patient groups
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Central trial contact
Barry Seifer, MFA; Richard A Detweiler, Ph.D.
Data sourced from clinicaltrials.gov
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