Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477354
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-05
Brief Title:
ACEMg for Hearing Preservation and Tinnitus Mitigation
Sponsor:
Keep Hearing Inc
Organization:
Keep Hearing Inc
Study Overview
Official Title:
ACEMg Phase IV Real-World Data Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACEMgRWD
Brief 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 753 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
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
Detailed 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 US 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 N190 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 N97 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 N93 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 752 N70 of those in the treatment group N93 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 httpsosfiopreprintsosfuw7tq
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
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 US 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 N190 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 N97 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 N93 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 752 N70 of those in the treatment group N93 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 httpsosfiopreprintsosfuw7tq
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None