Effect of the Administration of L-arginine vs. Placebo on the vHIT Result, Vestibular Caloric Tests and Symptoms of Patients Diagnosed With Presbyvestibulopathy.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Baseline Video Head Impulse Test vHIT
研究概览
简要总结
Presbivestibulopathy is defined as a chronic vestibular syndrome characterized by bilateral vestibulopathy verified with vestibular tests. These tests objectively assess vestibular function: video Head Impulse Test (v-HIT) and Vestibular Caloric Tests. Also, there are some questionnaires that serve us for monitoring and prognosis (Dizziness Handicap Inventory). There is currently no specific treatment for presbyvestibulopathy. The objective of this study is to evaluate the effect of L-arginine vs. placebo on symptoms, changes in the results of vHIT tests of patients diagnosed with presbyvestibulopathy. It will be conducted a randomized, double blind, placebo controled clinical trial. Patients will be men and women who meet the diagnostic criteria for Presbyvestibulopathy of the Barany Society. The sample size will be 12 patients per group. The patients in the experimental group will receive L-arginine at a dose of 3 grams divided into three doses of 1 g (capsules) every 8 hours, for 3 months. Patients in the control group will receive placebo at the same dosage. All patients will receive vestibular rehabilitation exercises. At the beginning and the end of the intervention , the following tests will be carried out: vertigo disability questionnaire, vHIT tests, and the Up and Go time test.
详细描述
Vertigo is a common cause in the otorhinolaryngology consultation; a high incidence of this condition has been reported, since there are reports indicating that up to 80% of the world population has presented an episode of vertigo at some stage of their lives.
In Germany, it has been reported a prevalence of moderate to severe vestibular vertigo is reported, calculated using a representative sample of a 22.9% in adults of 18 to 79 years. In a report of the United States Emergency Department, it has been reported that 3.3% of the first-contact consultations are due to dizziness, of which 32.9% wer of otological or vestibular origin.
Vertigo is classified into two categories: vertigo of central origin and peripheral vertigo. Peripheral vertigo, object of study of this investigation, is originated in the vestibular system, located in the inner ear. Among the differential diagnoses of vertigo of peripheral origin we find presbivestibulopathy, which is a condition characterized by bilateral vestibular dysfunction proven with objective diagnostic tests such as video HIT (vHIT), vestibular caloric tests, among others. In addition, the diagnostic must be done in people over 60 years, and other diagnostic criteria established by the diagnostic criteria for Presbyvestibulopathy of the Barany Society.
The treatment of vertigo, as well of the presbyvestibulopathy, is aimed to stabilize the pathological fluctuations in peripheral vestibular function, as well as promoting central compensation in case of a permanent deficit in vestibular function. Therefore, the drugs used for its treatment their purpose is to regulate the decompensated vestibular activity and to improve the symptoms, but not to suppress the cause that originates the pathology since the mechanism of action of the disease is not well established.
Currently, there is not a first-choice medication for the treatment of vertigo in general, much less for presbyvestibulopathy, since none has show high efficacy and low presence of adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients will be assigned by simple randomization using a table of random numbers to the pharmacological intervention groups.
The study treatment and treatment assignment codes will be kept in custody by someone outside the research team. In addition, it will be in charge of the delivery, reception and meticulous counting of the capsules to guarantee the blindness and adherence to the treatment by the patients.
This study is considered double-blind since both the principal investigator and the patient are unaware of the pharmacological intervention to which the patients will be assigned. Blinding will be possible thanks to the homologation of the drug and the placebo in both groups with capsules identical in shape, size and colour. In the same way, the medicine will be delivered in bottles of the same size, shape and color, identified only with the allocation code.
The blind may be broken in the presence of serious adverse events.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women.
- •Age over 60 years.
- •That patient meets the diagnostic criteria established for presbyvestibulopathy by the Classification Committee of the Barany Society:
- •Chronic vestibular syndrome (al least 3 months duration) with at least 2 of the following symptoms:
- •Postural imbalance or unsteadiness
- •Gait disturbance
- •Chronic dizziness
- •Recurrent falls
- •Mild bilateral peripheral vestibular hypofunction documented by at leat 1 of the following:
- •VOR gain measured by video-HIT between 0.6 and 0.8 bilaterally
- •VOR gain between 0.1 and 0.3 upon sinusoidal stimulation on a rotatory chair (0.1 Hz, Vmax=50-60°/sec)
- •Reduced caloric response (sum of bithermal saccadic peak velocity (SPV) on each side between 6 and 25°/sec)
- •Age ≥60 years
- •Not better accounted for by another disease or disorder
- •Consent under information
排除标准
- •Not being able to rule out the use of antivertigo drugs 1 week prior to study entry.
- •Use of vasodilator drugs or antihistamines.
- •Orthostatic hypotension
- •Cognitive deficit of the patient that prevents him from understanding the implications of the study.
- •Known uncontrolled liver or kidney disease.
- •Known hypersensitivity to study drugs.
- •Chronic use of drugs with an anticoagulant effect.
- •Bronchial asthma.
- •Elimination Criteria:
- •Treatment adherence <80% evaluated through registration in an adherence diary and capsules count
- •Presence of serious adverse events
- •Withdrawal of consent under information
研究组 & 干预措施
L-arginine
L-arginine 3 grams per day, divided into doses of 1 g every 8 hours during 90 days.
干预措施: L-arginine (Drug)
Placebo
Starch 1 gr every 8hr, during 90 days.
干预措施: Placebo (Other)
结局指标
主要结局
Baseline Video Head Impulse Test vHIT
时间窗: Pre-intervention
The vHIT is a simple, rapid test to assess vestibular function. It is based on the physiological aspects of the vestibular ocular reflex (VOR). VOR is a rapid reflex with a duration of 7 to 10 milliseconds and consists of the ability to keep the gaze fixed on an object with rapid and unexpected movements of the head. This study has a specificity and sensitivity of 100% to evaluate the VOR.
Final Video Head Impulse Test vHIT
时间窗: Final (after 90 days of intervention)
The vHIT is a simple, rapid test to assess vestibular function. It is based on the physiological aspects of the vestibular ocular reflex (VOR). VOR is a rapid reflex with a duration of 7 to 10 milliseconds and consists of the ability to keep the gaze fixed on an object with rapid and unexpected movements of the head. This study has a specificity and sensitivity of 100% to evaluate the VOR.
Baseline Dizziness Handicap Inventory
时间窗: Pre-intervention
Questionnaire that helps us to know the degree of emotional, functional and physical disability of patients diagnosed with presbyvestibulopathy. In addition, it has been used by different authors as a prognostic value, to know the improvement of pre- and post-treatment patients.
Final Dizziness Handicap Inventory
时间窗: Final (after 90 days of intervention)
Questionnaire that helps us to know the degree of emotional, functional and physical disability of patients diagnosed with presbyvestibulopathy. In addition, it has been used by different authors as a prognostic value, to know the improvement of pre- and post-treatment patients.
次要结局
- Final Time up and go Test(Final (after 90 days of intervention))
- Initial Audiometry(Pre-intervention)
- Final Audiometry(Final (after 90 days of intervention))
- Baseline Time up and go Test(Pre-intervention)
- Adverse events(Final (after 90 days of intervention))
研究者
Martha De Nuestra Señora De San Juan Rodríguez Sahagún
Investigator
Centro Universitario de Tonalá