ACEMg (Soundbites) Hearing Preservation, Tinnitus and Hyperacusis Relief Otology Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Subjective measure of preservation or improvement of inner ear auditory function
研究概览
简要总结
ACEMg (Soundbites) is a neuroprotectant supplement designed to block the initiating biological events in the inner ear leading to inner ear hearing loss, sensorineural hearing loss, SNHL, which accounts for more than 90% of all hearing loss. SNHL is so common it is called hearing loss. There is no cure for SNHL.
The 24-week OTIS 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.
The study also aims to assess the potential of ACEMg to relieve tinnitus, hyperacusis, and hearing sensitivity symptoms. These symptoms are often correlated with SNHL; relief from tinnitus, hyperacusis and hearing sensitivity were were not measured in the previous two-year study.
The OTIS 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 SNHL at the beginning? Second, do participants who self-report tinnitus, hyperacusis, or hearing sensitivity symptoms at the start of their test report reduced symptoms at the end?
Participants must be eighteen years of age and older and self-report hearing loss and/or tinnitus. The study is conducted at home using a smartphone app and a web-based assessment and data reporting tool developed for this study.
The study is conducted at home using an online hearing test and short surveys on tinnitus and hyperacusis. The tests are completed three times: Baseline tests are taken before participants begin to take ACEMg softgel capsules daily. The Test is repeated at about 11 and 24 weeks. Assessment scores at the beginning of the study will be compared with scores at the end.
Participation in the study is free.
详细描述
OVERVIEW
The 2-year Soundbites Real World Evidence study used otoacoustic emissions examinations conducted by an audiologist to assess auditory function objectively. Soundbites was clinically proven to preserve or improve hearing for 75.3% of those who took it daily. Among those who benefited, hearing loss stopped for half and improved for the other half. Most of the benefits happened within the first 6 months. Results continued with ongoing use.
ACEMg and tinnitus
ACEMg was not designed to address tinnitus or hyperacusis, and the 2-year study did not assess either. Nevertheless, since ACEMg became available as Soundbites softgel capsules in 2017, reports from customers with tinnitus and from audiologists treating patients with tinnitus or hyperacusis indicate that ongoing daily use of Soundbites relieves tinnitus and hyperacusis symptoms for some.
Assessing ACEMg for tinnitus symptom relief
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tinnitus self-reported at the baseline survey, or
- •Hearing loss assessed at the baseline test
排除标准
- •No tinnitus self-reported at the baseline survey, or
- •No hearing loss assessed at the baseline test
- •Previous use of ACEMg (Soundbites)
结局指标
主要结局
Subjective measure of preservation or improvement of inner ear auditory function
时间窗: Time point zero; 12 and 24 weeks.
Hearing assessments using the hearWHO digits-in-noise test
Tinnitus symptom relief
时间窗: Time point zero; 12 and 24 weeks.
Subjective assessment of tinnitus symptoms using the tinnitus survey
次要结局
未报告次要终点