EarGenie Minimum Viable Product (MVP) Performance Evaluation: Sensitivity and Specificity of a Test of Sound Detection and Discrimination Using Functional Near-infrared Spectroscopy (fNIRS) in a Single Group Trial of Normal Hearing Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.
研究概览
简要总结
This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants. The EarGenie MVP tests for detection and discrimination of sounds will be administered, and the sensitivity and specificity of the tests will be estimated for a range of sound levels (detection) and speech sound contrasts (discrimination).
详细描述
Procedures:
All procedures will be carried out in a single test session.
Determination of infant eligibility will be undertaken by confirming that the infant has passed hearing screening or diagnostic audiological assessment and is under the age of 2 years.
Before completing the fNIRS tests, the infant will undergo otoscopy and tympanometry to exclude possible temporary conductive hearing loss associated with abnormal tympanometric results. These are standard audiological procedures. If the infant has abnormal tympanometric results in both ears on the day, the test session will be rescheduled. The parent/guardian will be advised of the finding and its possible consequences (possible conductive hearing loss, possible progression to acute otitis media) and advised to seek medical advice should the infant show signs of illness or if hearing loss is suspected.
All assessments in the fNIRS test session will be undertaken by qualified paediatric audiologists who are trained in the fNIRS procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each infant must meet all of the following criteria to be enrolled in this trial:
- •Is between the ages of 1 and 24 months at the time of fNIRS testing.
- •Has no known hearing loss, having either passed newborn hearing screening or diagnostic audiological assessment.
- •Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
排除标准
- •Infants with skin conditions such as cradle cap, eczema, or other skin conditions on the head will be excluded.
- •There are no additional exclusion criteria other than not meeting the inclusion criteria.
结局指标
主要结局
Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.
时间窗: Up to 18 months
The primary outcome 1 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the detection test for three audible sound levels (65, 50, 35 dBSPL) within the comfortable loudness range. Sensitivity for the detection test will be estimated as the proportion of infants for whom the test result showed a positive detection and specificity will be estimated as \[1- the proportion of infants whose test result for a control condition (silence) showed a (false) detection\].
Performance of the EarGenie test of speech discrimination for a range of speech sound contrasts in normal-hearing infants
时间窗: Up to 18 months
The primary outcome 2 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the discrimination test for three difference speech sound contrasts differing in difficulty (BA/TEA, BA/BEE, and BA/GA), all presented at 65 dB SPL.
次要结局
未报告次要终点
研究者
Colette McKay
Leader, Translational Hearing Research and Principal Scientist
The Bionics Institute of Australia