Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Ocular Vestibular Evoked Myogenic Potential (oVEMP):
研究概览
简要总结
The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires and vestibular and postural assessments.
详细描述
Balance problems in children are an overlooked issue in the Danish healthcare system. Dysfunction of the vestibular system, i.e. vestibular dysfunction (VD), can have significant consequences for children's development and quality of life.
In particular, children with sensorineural hearing loss are at risk of developing VD. Hence, VD has been reported in 14 % to 91 % of children with sensorineural hearing loss. The close anatomical and embryological relationship between the hearing system and the vestibular system may of course explain this correlation.
The investigators aim for a child friendly and reliable vestibular test protocol in the study. According to the investigators studies as well as international reports, the investigators have chosen a vestibular test protocol with Video Head Impulse Test (v-HIT), cervical and ocular Vestibular Evoked Myogenic Potential (c and oVEMP) as the tests are feasible, valid, and child friendly. To evaluate overall balance ability, the children are tested on a Computerized Dynamic Posturography.
The aim of the study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss.
Hypothesis: The investigators expect that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children in the age of 3-10 years
- •Uni- or bilateral sensorineural hearing loss > 20 dB bone conduction pure tone average measured at frequencies 0.5, 1, 2, 4 kHz
- •Written informed consent from the parents.
排除标准
- •Previous inner ear surgery
- •Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.
- •Congenital nystagmus
- •Compromised eye muscle mobility
- •VEMP-electrode allergy
- •History of symptomatic head or neck trauma
- •Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)
研究组 & 干预措施
Children with sensorineural hearing loss
Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
干预措施: video Head Impulse Test (Diagnostic Test)
Children with sensorineural hearing loss
Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
干预措施: Cervical Vestibular Evoked Myogenic Potential (Diagnostic Test)
Children with sensorineural hearing loss
Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
干预措施: Ocular Vestibular Evoked Myogenic Potential (Diagnostic Test)
Children with sensorineural hearing loss
Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
干预措施: Computerized Dynamic Posturography (Diagnostic Test)
Children with sensorineural hearing loss
Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
干预措施: Dizziness Handicap Inventory for patient caregivers (Other)
结局指标
主要结局
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
时间窗: Measured at baseline.
Outcome measures: latency N1 and latency P1 in milliseconds
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
时间窗: Measured at baseline.
Outcome measures: latency P1 and latency N1 in milliseconds (ms)
Computerized Dynamic Posturography (CDP)
时间窗: Measured at baseline.
Outcome measures: Sensory Organization Test (SOT): * Average equilibrium score (ES) for SOT1-6. Equilibrium scores is the average of three trials for each of the six conditions SOT1-6. * The SOT Composite score. It is a weighted average of the six conditions (SOT1-6) with greater weight given to the more difficult conditions. * The preference score. The preference score = (SOT3 + SOT6) / (SOT2 + SOT5)).
video Head Impulse Test (vHIT)
时间窗: Measured at baseline.
Outcome measures: mean VOR gain
次要结局
- Vestibular dysfunction(Measures at baseline)
- Dizziness Handicap Inventory for patient caregivers (DHI-PC):(Measured at baseline.)
研究者
Signe Fiil Bønløkke
Principal Investigator
Gødstrup Hospital