The Effect of Caffeine on the Narcoleptic Patients
Condition: Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.

        1. Interview Questionnaire:

           For collecting data for this study, questionnaire well be designed.

           The questionnaire consisted of four parts to elicit the following information:

           A) Socio-demographic Data

             -  Personal data: The name of the participant, age, sex, educational level, and
                residence.

             -  Social habits: The smoking status

             -  Activity level: Mild, moderate or intense physical activity.

           B) Medical information:

             -  The occurrence of Narcolepsy with or without cataplexy.

             -  The occurrence of chronic diseases (hypertension, hyperlipidemia, cardiac diseases,
                diabetes and obesity).

           C) Caffeine expectancy & consumption, modified from:

             -  Caffeine expectancy questionnaire (CaffEQ) is a self-report measure, which assesses
                a range of expectancies for caffeine, and Sleep Disturbance (Huntley & Juliano,
                2007).

             -  The Caffeine Consumption Questionnaire (CCQ) used to produce a typical week's
                average estimate of caffeine consumption in milligrams (Heaton, 2010).

           D) Daytime sleepiness Scales :

             -  Stanford Sleepiness Scale (SSS)

             -  The Karolinska Sleepiness Scale (KSS)

        2. Anthropometric measurements:

           The four selected anthropometric measures, see below:

             -  Weight

             -  Height for calculating body mass index (BMI)

             -  Waist circumference

             -  Hip circumference

        3. Indirect calorimetry An automated metabolic measuring cart used for determining Energy
           Expenditure and for providing key information about the nutrient mixture catabolized for
           energy by measuring the rates of O2 consumption (VO2) and CO2 production (VCO2), the
           device name is QUARK.

        4. Body Composition Measurement:

           The five variables selected for body composition measurements are:

             -  Fat mass

             -  Muscle mass

             -  Bone mass

             -  Total body water

             -  Visceral fat rating The body composition machine will be used is Bioelectrical
                impedance analysis (Tanita BC-418, Japan).

        5. Blood biochemistry tests:

           Fasting blood glucose, lipids Profile, CBC, LFT, CRP, Bone Profile, Vit D. Biochemical
           measurements will be done at KKUH, it is equipped with all needed matching to run this
           study and has well-trained technician and statics to help in performing the test needed.

        6. Eye Blink Measurement. Setting/Procedure

      In the day of study, subject need to come fasting overnight so their fasting blood glucose
      levels and lab test sample will be taken. Then the Anthropometric, Body Composition &
      Indirect calorimetry Measurement for the subject will be documented. The sample will be
      randomly divided using a software and the tablets will be identically packaged by the
      pharmacist in opaque capsules and administered orally in a double- blind setting to one of
      the following Groups:

        -  Group one: will receive 200 mg Caffeine capsule + water.

        -  Group two: will receive Placebo (fiber capsule) + water.

      Then instruct the patients to take the medication/placebo in the morning for 1 week and come
      back for reassessment:

        -  Random Blood sugar will be taken

        -  Blood Pressure will be measured.

        -  Eye Blink Measurement

        -  Daytime sleepiness Scales (part of the questioner data will be filled) We will have a
           baseline assessment, 1st assessment after single dose of 200 mg Caffeine or placebo and
           second assessment after one week of chronic use of medication in a dose 200 mg During
           the patient waiting time, the Interview Questionnaire will be filled.

      Data management:

      Data will be categorized to age, sex, social, anthropometric measurements, biochemistry lab
      test, psychological and medical status.

      Statistical analysis Data will be entered and statistically analyzed by SPSS software. ANOVA
      will be used to differentiate among treatment groups. In all the statistical comparisons,
      differences with p < 0.05 will be considered to be significant.

      Steps for assuring data quality include:

        -  Training: Educate data collectors in a structured manner.

        -  Data completeness: Using the hospital program (Cerner) that give immediate feedback on
           issues such as missing or out-of-range values & Excel software

        -  Data consistency: Compare across sites and over time.

        -  Data dictionary will be used e.g World Health Organization Drug Dictionary, Cerner
           program record for normal ranges.

      Ethical consideration The study was approved by KKUH Ethical committee, Saudi Food & Drug
      Authority & Saudi Clinical Trial Registry.
    

Intervention name(s): Vivarin; Fiber
Intervention type(s): Drug; Drug
Intervention description(s): Adenosine is an endogenous sleep-promoting substance with neuronal inhibitory effects. Adenosine has been proposed to be a sleep-inducing substance accumulating in the brain during prolonged wakefulness. Caffeine is an adenosine receptor antagonist. It inhibits a part of the sleep cycle and, in turn, promotes the wakeup state. Caffeine results in the release of norepinephrine, dopamine and serotonin in the brain and the increase of circulating catecholamines, consistent with reversal of the inhibitory effect of adenosine.Vivarin Drug class :Central nervous system (CNS) stimulants.; Fiber will be used as placebo.
Other intervention name(s): 1,3,7-Trimethylpurine-2,6-dione; C8H10N4O2; caffeine citrate; Nutrisource Fiber
Intervention MeSH terms: Caffeine; Caffeine citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Caffeine; Caffeine citrate; Neurological disorder; Excessive daytime sleepiness; Orexin; adenosine antagonist