Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).
研究概览
简要总结
Vestibular neuritis is a brutal and continuous dizzying syndrome of peripheral (vestibular) origin without cochlear or other associated involvement. Specifically, vestibular neuritis is inflammation of the nerve that innervates the vestibular canals (the inner ear). It is characterized by the sudden onset of intense and prolonged vertigo accompanied by postural imbalance, nausea and vomiting, without hearing impairment or other neurological symptoms. Vestibular neuritis is the second cause of peripheral vertigo after benign paroxysmal positional vertigo. It represents approximately 7% of patients consulting for vertigo. The purpose of this study is to evaluate if wearing Boarding Ring glasses can be accelerated vestibular compensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Only the investigator carrying out the follow-up consultations is blind.
After examination by the ENT specialist (otorhinolaryngologist) who will diagnose vestibular neuritis, the patient will be randomized into one of three groups. The clinical follow-up will be performed by another practitioner, who will not know in which arm the patient is included (the patient will come to the consultation without his glasses). Only the practitioner who realized the randomization and the patient will have information about the arm in which they are located.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients,
- •patient with vestibular neuritis defined by appearance of continuous rotating vertigo with nausea
- •patient with spontaneous horizonto-rotating nystagmus beating towards the healthy ear
- •patient with a postural deviation towards the affected ear;
- •vestibular hyporeflexia measured at the caloric tests greater than 25%
- •patient who has given free, enlighten and written consent
排除标准
- •patient with a history of vertigo of vestibular origin or with vertigo developing for more than 4 days
- •patient with associated hearing loss or tinnitus
- •patient with an motor ocular abnormality of central origin
- •patient refusal or inability to consent
研究组 & 干预措施
Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Caloric test (Diagnostic Test)
Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Measurement of the speed of Nystagmus (Diagnostic Test)
Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Angle of deviation at Fukuda (Diagnostic Test)
Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Alexander's degree of nystagmus (Diagnostic Test)
Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: EHTEV questionnaire (Other)
Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: EEV questionnaire (Other)
Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: anxiety VAS (Other)
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Caloric test (Diagnostic Test)
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Measurement of the speed of Nystagmus (Diagnostic Test)
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Angle of deviation at Fukuda (Diagnostic Test)
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Alexander's degree of nystagmus (Diagnostic Test)
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: EHTEV questionnaire (Other)
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: EEV questionnaire (Other)
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: anxiety VAS (Other)
No glasses
Realization of the following examinations WITHOUT glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Caloric test (Diagnostic Test)
No glasses
Realization of the following examinations WITHOUT glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Measurement of the speed of Nystagmus (Diagnostic Test)
No glasses
Realization of the following examinations WITHOUT glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Angle of deviation at Fukuda (Diagnostic Test)
No glasses
Realization of the following examinations WITHOUT glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: Alexander's degree of nystagmus (Diagnostic Test)
No glasses
Realization of the following examinations WITHOUT glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: EHTEV questionnaire (Other)
No glasses
Realization of the following examinations WITHOUT glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: EEV questionnaire (Other)
No glasses
Realization of the following examinations WITHOUT glasses :
- caloric tests,
- measurement of the speed of Nystagmus,
- angle of deviation in Fukuda,
- Alexander's degree of nystagmus,
- EHTEV and EEV questionnaires,
- anxiety VAS
干预措施: anxiety VAS (Other)
结局指标
主要结局
Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).
时间窗: 7 day
次要结局
- Duration of hospitalization (for hospitalized patients)(1 year)
- Speed of nystagmus(1 year)
- Alexander's degree of nystagmus(1 year)
- Anxiety visual analog scale(1 year)
- European Vertigo Evaluation Scale (EEV questionnaire)(1 year)
- Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)(1 year)
- Vestibular deficit at caloric tests(1 year)
- Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12(1 year)