The Effects of the Erchonia Hearing Laser on Word Recognition in Hearing Impaired Individuals Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.
研究概览
简要总结
The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.
详细描述
Sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. Sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. In most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' Current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. Low Level Laser Therapy was first applied for the treatment of inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980's. Hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. Low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of ATP. The resultant surge in ATP production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Sensorineural hearing loss.
- •Mild or greater degree.
- •Adult onset.
- •Gradual onset.
- •Hearing loss stable over past 12 months.
- •Etiology of presbyacusis or noise-induced hearing loss.
- •Unaided word recognition score between 28% and 86%.
- •English as primary spoken language.
- •Willing and able to abstain from other treatments or medications to improve hearing ability.
- •Willing and able to abstain from work or other activities that involve loud noise exposure.
排除标准
- •Central auditory processing disorder.
- •Active/recurrent middle ear infection.
- •Meniere's disease.
- •Tympanic membrane perforation/tubes.
- •Cochlear implant.
- •Removal of acoustic neuroma.
- •Hyperacusis/misphonia.
- •Photosensitivity disorder.
- •Active infection/wound in head/ear region.
- •Pregnant/lactating.
- •Serious mental health illness.
- •Significant developmental disability/cognitive impairment.
- •History of drug/alcohol abuse.
- •Involvement in litigation/worker's compensation/disability benefits for hearing loss.
- •Other research participation in past 90 days.
- •Use of ototoxic medications known to cause temporary or permanent hearing loss.
结局指标
主要结局
Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.
时间窗: baseline and one week
Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. The change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.
次要结局
未报告次要终点