Prospective, Single Centre Cohort Study on the Impact of Binaural Audition on Postural Performance and Orientation in Healthy Subjects and Patients With Cochlear Implants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Presence of a sensation of rotation due to a turning sound source
研究概览
简要总结
This is a prospective research study talking place at University hospital of Dijon and requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants and 10 patients with bilateral cochlear implants to carry out:
- an audio-vestibular examination,
- a videonystagmoscopic study,
- a posturography study and
- a movement study. The aim of the study is to evaluate the impact of binaural audition on postural performance and orientation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have provided written consent
- •Patients with health insurance cover
- •Age between 18 and 75 years old
- •For subjects with implants: unilateral or bilateral cochlear implants for more than one year
- •For healthy subjects: absence of known audio-vestibular disorders (deafness, vertigo)
排除标准
- •Patients dependent on an aid to move around (cane, wheelchair, crutch, ...)
- •Patients under guardianship
- •Pregnant women
- •Disability interfering with understanding or carrying out instructions
- •Associated sensory or motor disorders
研究组 & 干预措施
healthy subjects
干预措施: Posturographies study (Other)
healthy subjects
干预措施: Audio-vestibular examination (Other)
healthy subjects
干预措施: Videonystagmoscopic study (Other)
patients with unilateral cochlear implants
干预措施: Audio-vestibular examination (Other)
patients with unilateral cochlear implants
干预措施: Videonystagmoscopic study (Other)
patients with unilateral cochlear implants
干预措施: Posturographies study (Other)
patients with bilateral cochlear implants
干预措施: Audio-vestibular examination (Other)
patients with bilateral cochlear implants
干预措施: Videonystagmoscopic study (Other)
patients with bilateral cochlear implants
干预措施: Posturographies study (Other)
结局指标
主要结局
Presence of a sensation of rotation due to a turning sound source
时间窗: Baseline
Modification of posturography parameters in the presence and absence of a de turning sound source
时间窗: Baseline
Time to cover a distance of 3metres in a straight line and number of steps used
时间窗: Baseline
次要结局
未报告次要终点