Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- HF DPOAE measurement
研究概览
简要总结
Among the objective non-invasive audiological explorations the distorsion products of otoacoustic emissions (DPOAE) allow to quickly assess the function of the cochlear outer hair cells (without the active participation of the subject). This technique is used in newborn screening. While humans are able to perceive sounds in a frequency range of 20Hz to 20kHz, routine clinical audiological assessment is only concerned with frequencies between 1-4kHz.
This obscures the importance of high frequencies (HF) which can be easily assessed by DPOAEs. In young children, the perception of these high frequencies could also play an important role in language acquisition.
The main objective of this study is to evaluate the relationship between subtle high-frequency hearing impairment, as assessed by the DPOAE (non-invasive, rapid and simple audiological test), and language delay or difficulties in a pre-, peri- and school-age pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for case (children with language disorder):
- •Normal hearing (after an audiometry test, even if an ENT consultation has been carried out beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP <20dB HL)
- •Free and informed consent of the parental authority and the patient
- •Affiliated to the social security system
- •Presenting a developmental language acquisition disorder (score according to the EVALO / EVALEO test)
- •For children between 15 and 17 years of age, completion of the EVALEO test before their 16th birthday
- •Inclusion Criteria for control (children without language disorder) :
- •Normal hearing (after an audiometry test, even if an ENT consultation has been performed beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP <20dB HL)
- •Free and informed consent of the parental authority and the patient
- •Enrolled in the social security system
排除标准
- •Hearing disorder identified during the inclusion visit (presence of cerumen or foreign body in the earwax plug or foreign body in the external auditory canal, tympanometry suggesting a middle ear disorder, audiometry with thresholds outside the normal thresholds outside the normal range (0-20dB HL), absence of responses in (0-20dB HL), absence of responses in acoustic otoemissions or acoustic distortion products) on conversational frequencies between 500Hz and 4kHz.
- •Declaration by the parents of an ENT follow-up for a hearing disorder and/or a speech therapy for a language disorder
- •Refusal of participation evoked by the subject
结局指标
主要结局
HF DPOAE measurement
时间窗: Day 1
at frequencies 4265, 4688, 5154, 5666, 6229, 6847, 7527, 8275, 9096 and 10000 Hz
次要结局
- Presence or absence of HF DPOAE(Day 1)
- Laterality of hearing loss at the DPOAE level with a classification into 3 groups(Day 1)
- Determination of the average hearing loss (baseline pure tone audiometry)(Day 1)
- Severity and type of language impairment assessed by the EVALO/ EVALEO(day 1)
- Functional status of the middle ear(Day 1)