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NarcolepsyPhase 1/2NCT02832336

The Effect of Caffeine on the Narcoleptic Patients

A Phase 1/2 study testing Vivarin and Fiber in people with Narcolepsy, run by King Saud University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Narcolepsy
What is being tested?
Vivarin and Fiber
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteSaudi Arabia
Study dates
1 Oct 2016to 7 May 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Case -group should be Narcoleptic with cataplexy

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • King Khalid University Hospital:King Saud Medical City

    Riyadh

Other trials in Saudi Arabia

About this study

Official title: The Effect of Caffeine on the Narcoleptic Patients Randomized Controlled Clinical Trial

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.

Read the 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:
  2. 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.
  1. Medical information:
  • The occurrence of Narcolepsy with or without cataplexy.
  • The occurrence of chronic diseases (hypertension, hyperlipidemia, cardiac diseases, diabetes and obesity).
  1. 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).
  1. Daytime sleepiness Scales :
  • Stanford Sleepiness Scale (SSS)
  • The Karolinska Sleepiness Scale (KSS)
  1. Anthropometric measurements: The four selected anthropometric measures, see below:
  • Weight
  • Height for calculating body mass index (BMI)
  • Waist circumference
  • Hip circumference
  1. 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.
  2. 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).
  1. 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.
  2. 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.

Conditions
Narcolepsy
Being tested
Vivarin, Fiber
Keywords
Caffeine, Caffeine citrate, Neurological disorder, Excessive daytime sleepiness, Orexin, adenosine antagonist
Medical subject headings
Narcolepsy, Nervous System Diseases, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VivarinDrug

    Also called 1,3,7-Trimethylpurine-2,6-dione, C8H10N4O2, caffeine citrate

    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.

  • FiberDrug

    Also called Nutrisource Fiber

    Fiber will be used as placebo.

Study groups in NCT02832336
Study groupRoleWhat they receive
CaffeineExperimentalCaffeine 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.
Receives: Drug: Vivarin
FiberPlacebo comparatorFiber powder will be used as placebo, Form of Administration:Oral in veg white capsule form (size 1)
Receives: Drug: Fiber

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 7 days

Secondary outcomes (2)

  1. 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).

    Measured: 7 days

  2. 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).

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion11 May 2017
  4. Study completion7 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832336
Sponsor's protocol ID
IRB:E-15-1484
Other IDs
SFDA # 16022302
Status last verified
Feb 2019
First submitted
9 Jun 2016
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Possibility to share most data.

Publications

  • 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.

    PubMed 17943086

  • 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.

    PubMed 2265922

  • Alkaabi J, Al-Dabbagh B, Saadi H, Gariballa S, Yasin J. Effect of traditional Arabic coffee consumption on the glycemic index of Khalas dates tested in healthy and diabetic subjects. Asia Pac J Clin Nutr. 2013;22(4):565-73. doi: 10.6133/apjcn.2013.22.4.09.

    PubMed 24231017

  • BaHammam AS, Alenezi AM. Narcolepsy in Saudi Arabia. Demographic and clinical perspective of an under-recognized disorder. Saudi Med J. 2006 Sep;27(9):1352-7.

    PubMed 16951772

  • Beitinger PA, Fulda S, Dalal MA, Wehrle R, Keckeis M, Wetter TC, Han F, Pollmacher T, Schuld A. Glucose tolerance in patients with narcolepsy. Sleep. 2012 Feb 1;35(2):231-6. doi: 10.5665/sleep.1628.

    PubMed 22294813

  • Benowitz NL. Clinical pharmacology of caffeine. Annu Rev Med. 1990;41:277-88. doi: 10.1146/annurev.me.41.020190.001425.

    PubMed 2184730

  • Bruck D, Armstrong S, Coleman G. Sleepiness after glucose in narcolepsy. J Sleep Res. 1994 Sep;3(3):171-179. doi: 10.1111/j.1365-2869.1994.tb00125.x.

    PubMed 10607123

  • Burdakov D, Alexopoulos H. Metabolic state signalling through central hypocretin/orexin neurons. J Cell Mol Med. 2005 Oct-Dec;9(4):795-803. doi: 10.1111/j.1582-4934.2005.tb00380.x.

    PubMed 16364191

  • Chabas D, Foulon C, Gonzalez J, Nasr M, Lyon-Caen O, Willer JC, Derenne JP, Arnulf I. Eating disorder and metabolism in narcoleptic patients. Sleep. 2007 Oct;30(10):1267-73. doi: 10.1093/sleep/30.10.1267.

    PubMed 17969460

  • Chemelli RM, Willie JT, Sinton CM, Elmquist JK, Scammell T, Lee C, Richardson JA, Williams SC, Xiong Y, Kisanuki Y, Fitch TE, Nakazato M, Hammer RE, Saper CB, Yanagisawa M. Narcolepsy in orexin knockout mice: molecular genetics of sleep regulation. Cell. 1999 Aug 20;98(4):437-51. doi: 10.1016/s0092-8674(00)81973-x.

    PubMed 10481909

  • Cun Y, Tang L, Yan J, He C, Li Y, Hu Z, Xia J. Orexin A attenuates the sleep-promoting effect of adenosine in the lateral hypothalamus of rats. Neurosci Bull. 2014 Oct;30(5):877-86. doi: 10.1007/s12264-013-1442-8. Epub 2014 Jun 5.

    PubMed 24898402

  • Dahmen N, Bierbrauer J, Kasten M. Increased prevalence of obesity in narcoleptic patients and relatives. Eur Arch Psychiatry Clin Neurosci. 2001;251(2):85-9. doi: 10.1007/s004060170057.

    PubMed 11407443

  • Daniels E, King MA, Smith IE, Shneerson JM. Health-related quality of life in narcolepsy. J Sleep Res. 2001 Mar;10(1):75-81. doi: 10.1046/j.1365-2869.2001.00234.x.

    PubMed 11285058

  • Daniello A, Fievisohn E, Gregory TS. Modeling the effects of caffeine on the sleep/ wake cycle. Biomed Sci Instrum. 2012;48:73-80.

    PubMed 22846267

  • Darwish M, Kirby M, Robertson P Jr, Hellriegel ET. Interaction profile of armodafinil with medications metabolized by cytochrome P450 enzymes 1A2, 3A4 and 2C19 in healthy subjects. Clin Pharmacokinet. 2008;47(1):61-74. doi: 10.2165/00003088-200847010-00006.

    PubMed 18076219

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vivarin and Fiber in people with Narcolepsy, run by King Saud University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eye Blink Measurement (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832336, which also lists 50 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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