The Effect of Caffeine on the Narcoleptic Patients
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|ClinicalTrials.gov Identifier: NCT02832336|
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy||Drug: Vivarin Drug: Fiber||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Caffeine on the Narcoleptic Patients Randomized Controlled Clinical Trial|
|Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||May 11, 2017|
|Actual Study Completion Date :||May 7, 2018|
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.
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.
Placebo Comparator: Fiber
Fiber powder will be used as placebo, Form of Administration:Oral in veg white capsule form (size 1)
Fiber will be used as placebo.
Other Name: Nutrisource Fiber
- Eye Blink Measurement [ Time Frame: 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).
- Stanford Sleepiness Scale (SSS) [ Time Frame: 7 days ]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).
- The Karolinska Sleepiness Scale (KSS) [ Time Frame: 7 days ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832336
|King Khalid University Hospital:King Saud Medical City|
|Riyadh, Saudi Arabia|
|Principal Investigator:||Mona S Aldosari, Masteral||King Saud University|