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| ID | Type | Description | Link |
|---|---|---|---|
| SFDA # 16022302 | Registry Identifier | Saudi Clinical Trials Registry |
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| Name | Class |
|---|---|
| King Saud Medical City | OTHER_GOV |
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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.
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.
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
B) Medical information:
C) Caffeine expectancy & consumption, modified from:
D) Daytime sleepiness Scales :
Anthropometric measurements:
The four selected anthropometric measures, see below:
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.
Body Composition Measurement:
The five variables selected for body composition measurements are:
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.
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:
Then instruct the patients to take the medication/placebo in the morning for 1 week and come back for reassessment:
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:
Ethical consideration The study was approved by KKUH Ethical committee, Saudi Food & Drug Authority & Saudi Clinical Trial Registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine | Experimental | 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. |
|
| Fiber | Placebo Comparator | Fiber powder will be used as placebo, Form of Administration:Oral in veg white capsule form (size 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivarin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Eye Blink Measurement | 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). | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stanford Sleepiness Scale (SSS) | SSS is a daytime sleepiness Scales, using a 7-point Likert scale based on a series of statements that range from "feeling active, vital, alert, wide awake" to "almost in reverie, cannot stay awake, sleep onset appears imminent" describes how they feel at the time (Hoddes et.al,1973). | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona S Aldosari, Masteral | King Saud University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Khalid University Hospital:King Saud Medical City | Riyadh | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17943086 | Background | Adamantidis AR, Zhang F, Aravanis AM, Deisseroth K, de Lecea L. Neural substrates of awakening probed with optogenetic control of hypocretin neurons. Nature. 2007 Nov 15;450(7168):420-4. doi: 10.1038/nature06310. Epub 2007 Oct 17. | |
| 2265922 | Background | Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241. |
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Possibility to share most data.
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D009422 | Nervous System Diseases |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| C026189 | caffeine citrate |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
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| Fiber | Drug | Fiber will be used as placebo. |
|
|
| The Karolinska Sleepiness Scale (KSS) |
KSS is a daytime sleepiness Scales, using a 9-point Likert scale based on a self-reported, subjective assessment of the subject's level of drowsiness at the time (Akerstedt & Gillberg, 1990). |
| 7 days |
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |