The Effect of Caffeine on the Narcoleptic Patients Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Eye Blink Measurement
研究概览
简要总结
Caffeine may be playing a beneficial role in patients with narcolepsy. However, the relationship between caffeine and its effects on narcoleptic patients has not been examined, and it is also unclear whether caffeine provides a beneficial effect or not. Hence, the aim of this study is to assess the effects of caffeine consumption on daytime sleepiness and reaction time in narcoleptic patients.
详细描述
The participants will be recruited at the University Sleep Disorders Center, College of Medicine, King Saud University.
Narcolepsy diagnosis: Narcolepsy will be diagnosed based on the American Academy of Sleep Medicine International Classification of Sleep Disorders, 2014 (American academy of sleep medicine. International classification of sleep disorders (ICSD), 3rd ed. Darien, il: American academy of sleep medicine, 2014).
The study will be interventional, randomized, double-blind, placebo control study, to evaluate the effect of caffeine on Narcoleptic Adults (n=30) aged 18-45 years old, following up in the Sleep Disorders Center (SDC) at King Khalid University Hospital (KKUH).
Tools of the study:
The study tools included an interview questionnaire, anthropometric measurements, indirect calorimetry, body composition measurements, blood biochemistry tests & Eye Blink measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case -group should be Narcoleptic with cataplexy
排除标准
- •Individuals older than 45 years or younger than 18 years old.
- •Individuals complaining of any diseases or conditions that affect their dietary intake, as such : renal failure, liver failure, malabsorption problems, cardiac diseases ... etc.
- •Individuals having hypersensitivity to caffeine.
- •Individuals with medical conditions that cause sleepiness (like hypothyroidism) and pregnant or lactating females will be excluded.
研究组 & 干预措施
Caffeine
Caffeine is an adenosine receptor antagonist. It inhibits a part of the sleep cycle and, in turn, promotes the wakefulness state.
Generic name :Vivarin(1,3,7-trimethylxanthine), 200 mg/day for one week, Form of Administration:Oral in veg white capsule form (size 1) Drug Class:Central nervous system (CNS) stimulants.
干预措施: Vivarin (Drug)
Fiber
Fiber powder will be used as placebo, Form of Administration:Oral in veg white capsule form (size 1)
干预措施: Fiber (Drug)
结局指标
主要结局
Eye Blink Measurement
时间窗: 7 days
Blink total duration (BTD), which measures the duration of the closing, closed and reopening phases of each blink by using Optalert system, a glass frame carrying an IR transmitter and receiver bar that positioned below and in front of the eye, directed towards the lower edge of the upper eyelid allows for measurements of blink duration and eye closure time as an indicator of drowsiness and decreased vigilance.The eye blink measurement (Optalert) will be performed multiple times to measure the changes in the alertness level for each patient after single-dose intake and after daily medication intake.(The measuring instrument takes about 10-20 minutes).
次要结局
- Stanford Sleepiness Scale (SSS)(7 days)
- The Karolinska Sleepiness Scale (KSS)(7 days)
研究者
Mona Aldoasri
Principal Investigator
King Saud University