Noninvasive Cochlear Stimulation System
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Healthy
- 发起方
- Mayo Clinic
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies
- 状态
- 已完成
- 最后更新
- 4个月前
概览
简要总结
The purpose of this research is to develop a portable wearable hardware headset using a computer-based software that can establish the optimal stimulation parameters appropriate for medical and consumer environments for individuals with hearing impaired and normal hearing individuals.
研究者
入排标准
入选标准
- •\- Employee of Mayo Clinic.
排除标准
- •Pregnant.
- •Cochlear implants.
- •History of fluctuating sensorineural hearing loss.
- •Skin diseases of the head.
- •History of acute paroxysmal tachycardia.
- •History of trigeminal neuralgia.
- •Recent of paralysis of the facial nerve.
- •Recent cerebrovascular stroke.
结局指标
主要结局
Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies
时间窗: Baseline, approximately 2 hours
Evaluated by increasing the amplitude of the current input until the subject could hear a tone at 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz, 10,000 Hz, 12,500 Hz and 16,000 Hz. The mean electric current is reported in Milliampere (mA).
Speech Intelligibility in Quiet Environment
时间窗: Baseline, approximately 2 hours
Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. Subjects completed electrical word recognition testing in a quiet environment. Electrodes were placed at 3 unique locations (forehead, mastoid, neck) to measure how well speech could be delivered to the subject through the skin electrodes in a manner that would allow subjects to recognize words in a quiet environment. There were 2 experiments done for speech intelligibility. The first involved 20 subjects (outcome 2) and aimed to assess speech intelligibility performance in a basic, quiet environment without background noise. This phase focused on evaluating the fundamental hearing performance. Once it was established that speech intelligibility was satisfactory with electrical stimulation, we proceeded to test an additional 30 subjects in both quiet and noisy environments (outcome 3).
Speech Intelligibility in Quiet and Noisy Environments
时间窗: Baseline; approximately 2 hours
Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. Subjects completed electrical word recognition testing in a quiet, then a noisy environment. Electrodes were placed at 3 unique locations (mastoid, wrist, back) to measure how well speech could be delivered to the subject through the skin electrodes in a manner that would allow subjects to recognize words in a quiet and noisy environment. There were 2 experiments done for speech intelligibility. The first involved 20 subjects (outcome2) and aimed to assess speech intelligibility performance in a basic, quiet environment without background noise. This phase focused on evaluating the fundamental hearing performance. Once it was established that speech intelligibility was satisfactory with electrical stimulation, we proceeded to test an additional 30 subjects in both quiet and noisy environments (outcome3)