Effect of Caffeine Intake in Vestibular Function: A Randomized Triple-Blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- asymmetry rate - VEMP
研究概览
简要总结
Objective: Assess the effect of caffeine in the following vestibular function tests: Cervical Vestibular Evoked Potential (cVEMP), Ocular Vestibular Evoked Potential(oVEMP) and Caloric Test.
Methods: Randomized, prospective triple-blind, placebo controlled clinical trial. All participants underwent otoscopy, tympanometry, responded to the Profile of Mood State (POMS), submitted to the cVEMP, oVEMP and caloric tests. After that they received placebo or caffeine capsule (300mg) and repeated the procedures 45 minutes after.
详细描述
Trial design
This is a randomized, prospective triple-blind, placebo controlled clinical trial approved by the institutional review board under protocol number 1.399.322/16. Informed consent was obtained after a full explanation of the experimental procedure.
Participants
The sample was made up of medical students who agreed to participate as volunteers and had no hearing and/or vestibular complaints or other health problems that could affect the homeostasis of the vestibular system (problems in the cervical spine, cardiovascular problems, migraine, metabolic disorders, hormonal changes, psychiatric disorders, neurological diseases, use of prescription drugs continuously, smokers, alcoholics, illegal drug users).
Randomization, allocation and Blinding
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical students volunteers
- •Had no hearing and/or vestibular complaints
排除标准
- •Problems in the cervical spine
- •Cardiovascular problems
- •Metabolic disorders
- •Hormonal changes
- •Psychiatric disorders
- •Neurological diseases
- •Use of prescription drugs continuously
- •Alcoholics
- •Illegal drug users
研究组 & 干预措施
Non caffeine group
All participants underwent otoscopy and tympanometry, responded to the Profile of Mood State (POMS), submitted to the cVEMP, oVEMP and caloric tests in that order. After that they received placebo capsule (maize starch). After 45 minutes they again responded to the POMS, repeated the cVEMP, oVEMP and caloric test.
干预措施: Non caffeine (Dietary Supplement)
Caffeine group
All participants underwent otoscopy and tympanometry, responded to the Profile of Mood State (POMS), submitted to the cVEMP, oVEMP and caloric tests in that order. After that they received caffeine capsule (300mg). After 45 minutes they again responded to the POMS, repeated the cVEMP, oVEMP and caloric test.
干预措施: Caffeine (Dietary Supplement)
结局指标
主要结局
asymmetry rate - VEMP
时间窗: through study completion, an average of 3 months
wave latency - VEMP
时间窗: through study completion, an average of 3 months
Peak slow velocity (PSV) - Caloric test
时间窗: through study completion, an average of 3 months
Unilateral weakness or directional preponderance - Caloric test
时间窗: through study completion, an average of 3 months
次要结局
- Questionnaire - POMS(through study completion, an average of 3 months)
研究者
Alleluia Lima Losno Ledesma
Audiologist
Instituto Brasiliense de Otorrinolaringologia