Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2016-10-01
2018-05-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.
NCT01638403
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
NCT01006122
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
NCT00107796
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
NCT03748979
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
NCT03772314
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Vivarin
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
Fiber powder will be used as placebo, Form of Administration:Oral in veg white capsule form (size 1)
Fiber
Fiber will be used as placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vivarin
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
Fiber will be used as placebo.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King Saud Medical City
OTHER_GOV
King Saud University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mona Aldoasri
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mona S Aldosari, Masteral
Role: PRINCIPAL_INVESTIGATOR
King Saud University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
King Khalid University Hospital:King Saud Medical City
Riyadh, , Saudi Arabia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Benowitz NL. Clinical pharmacology of caffeine. Annu Rev Med. 1990;41:277-88. doi: 10.1146/annurev.me.41.020190.001425.
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.
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.
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.
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.
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.
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.
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.
Daniello A, Fievisohn E, Gregory TS. Modeling the effects of caffeine on the sleep/ wake cycle. Biomed Sci Instrum. 2012;48:73-80.
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.
Dresler M, Spoormaker VI, Beitinger P, Czisch M, Kimura M, Steiger A, Holsboer F. Neuroscience-driven discovery and development of sleep therapeutics. Pharmacol Ther. 2014 Mar;141(3):300-34. doi: 10.1016/j.pharmthera.2013.10.012. Epub 2013 Nov 1.
Engel A, Helfrich J, Manderscheid N, Musholt PB, Forst T, Pfutzner A, Dahmen N. Investigation of insulin resistance in narcoleptic patients: dependent or independent of body mass index? Neuropsychiatr Dis Treat. 2011;7:351-6. doi: 10.2147/NDT.S18455. Epub 2011 Jun 9.
Espana RA, McCormack SL, Mochizuki T, Scammell TE. Running promotes wakefulness and increases cataplexy in orexin knockout mice. Sleep. 2007 Nov;30(11):1417-25. doi: 10.1093/sleep/30.11.1417.
Flygare J, Parthasarathy S. Narcolepsy: let the patient's voice awaken us! Am J Med. 2015 Jan;128(1):10-3. doi: 10.1016/j.amjmed.2014.05.037. Epub 2014 Jun 12.
Hoddes E, Zarcone V, Smythe H, Phillips R, Dement WC. Quantification of sleepiness: a new approach. Psychophysiology. 1973 Jul;10(4):431-6. doi: 10.1111/j.1469-8986.1973.tb00801.x. No abstract available.
Honda Y, Doi Y, Ninomiya R, Ninomiya C. Increased frequency of non-insulin-dependent diabetes mellitus among narcoleptic patients. Sleep. 1986;9(1 Pt 2):254-9. doi: 10.1093/sleep/9.1.254.
Ingravallo F, Gnucci V, Pizza F, Vignatelli L, Govi A, Dormi A, Pelotti S, Cicognani A, Dauvilliers Y, Plazzi G. The burden of narcolepsy with cataplexy: how disease history and clinical features influence socio-economic outcomes. Sleep Med. 2012 Dec;13(10):1293-300. doi: 10.1016/j.sleep.2012.08.002. Epub 2012 Sep 28.
Jennum P, Ibsen R, Knudsen S, Kjellberg J. Comorbidity and mortality of narcolepsy: a controlled retro- and prospective national study. Sleep. 2013 Jun 1;36(6):835-40. doi: 10.5665/sleep.2706.
Johnston KL, Clifford MN, Morgan LM. Coffee acutely modifies gastrointestinal hormone secretion and glucose tolerance in humans: glycemic effects of chlorogenic acid and caffeine. Am J Clin Nutr. 2003 Oct;78(4):728-33. doi: 10.1093/ajcn/78.4.728.
Kaplan GB, Greenblatt DJ, Ehrenberg BL, Goddard JE, Cotreau MM, Harmatz JS, Shader RI. Dose-dependent pharmacokinetics and psychomotor effects of caffeine in humans. J Clin Pharmacol. 1997 Aug;37(8):693-703. doi: 10.1002/j.1552-4604.1997.tb04356.x.
Landolt HP. Sleep homeostasis: a role for adenosine in humans? Biochem Pharmacol. 2008 Jun 1;75(11):2070-9. doi: 10.1016/j.bcp.2008.02.024. Epub 2008 Mar 4.
Landolt HP, Retey JV, Tonz K, Gottselig JM, Khatami R, Buckelmuller I, Achermann P. Caffeine attenuates waking and sleep electroencephalographic markers of sleep homeostasis in humans. Neuropsychopharmacology. 2004 Oct;29(10):1933-9. doi: 10.1038/sj.npp.1300526.
Longstreth WT Jr, Koepsell TD, Ton TG, Hendrickson AF, van Belle G. The epidemiology of narcolepsy. Sleep. 2007 Jan;30(1):13-26. doi: 10.1093/sleep/30.1.13.
Mesa YR, Meira E Cruz MG. Narcolepsy with cataplexy after A/H1N1 vaccination - A case reported from Cuba. Sleep Sci. 2014 Mar;7(1):59-61. doi: 10.1016/j.slsci.2014.07.024. Epub 2014 Aug 22.
Nawrot P, Jordan S, Eastwood J, Rotstein J, Hugenholtz A, Feeley M. Effects of caffeine on human health. Food Addit Contam. 2003 Jan;20(1):1-30. doi: 10.1080/0265203021000007840.
Partinen M, Saarenpaa-Heikkila O, Ilveskoski I, Hublin C, Linna M, Olsen P, Nokelainen P, Alen R, Wallden T, Espo M, Rusanen H, Olme J, Satila H, Arikka H, Kaipainen P, Julkunen I, Kirjavainen T. Increased incidence and clinical picture of childhood narcolepsy following the 2009 H1N1 pandemic vaccination campaign in Finland. PLoS One. 2012;7(3):e33723. doi: 10.1371/journal.pone.0033723. Epub 2012 Mar 28.
Peacock J, Benca RM. Narcolepsy: clinical features, co-morbidities & treatment. Indian J Med Res. 2010 Feb;131:338-49.
Peall KJ, Robertson NP. Narcolepsy: environment, genes and treatment. J Neurol. 2014 Aug;261(8):1644-6. doi: 10.1007/s00415-014-7435-3. No abstract available.
Plaza-Zabala A, Maldonado R, Berrendero F. The hypocretin/orexin system: implications for drug reward and relapse. Mol Neurobiol. 2012 Jun;45(3):424-39. doi: 10.1007/s12035-012-8255-z. Epub 2012 Mar 20.
Poli F, Plazzi G, Di Dalmazi G, Ribichini D, Vicennati V, Pizza F, Mignot E, Montagna P, Pasquali R, Pagotto U. Body mass index-independent metabolic alterations in narcolepsy with cataplexy. Sleep. 2009 Nov;32(11):1491-7. doi: 10.1093/sleep/32.11.1491.
al Rajeh S, Bademosi O, Ismail H, Awada A, Dawodu A, al-Freihi H, Assuhaimi S, Borollosi M, al-Shammasi S. A community survey of neurological disorders in Saudi Arabia: the Thugbah study. Neuroepidemiology. 1993;12(3):164-78. doi: 10.1159/000110316.
Sakurai T, Amemiya A, Ishii M, Matsuzaki I, Chemelli RM, Tanaka H, Williams SC, Richardson JA, Kozlowski GP, Wilson S, Arch JR, Buckingham RE, Haynes AC, Carr SA, Annan RS, McNulty DE, Liu WS, Terrett JA, Elshourbagy NA, Bergsma DJ, Yanagisawa M. Orexins and orexin receptors: a family of hypothalamic neuropeptides and G protein-coupled receptors that regulate feeding behavior. Cell. 1998 Feb 20;92(4):573-85. doi: 10.1016/s0092-8674(00)80949-6.
Sakurai T, Mieda M, Tsujino N. The orexin system: roles in sleep/wake regulation. Ann N Y Acad Sci. 2010 Jul;1200:149-61. doi: 10.1111/j.1749-6632.2010.05513.x.
Sasaki K, Suzuki M, Mieda M, Tsujino N, Roth B, Sakurai T. Pharmacogenetic modulation of orexin neurons alters sleep/wakefulness states in mice. PLoS One. 2011;6(5):e20360. doi: 10.1371/journal.pone.0020360. Epub 2011 May 27.
Sellayah D, Bharaj P, Sikder D. Orexin is required for brown adipose tissue development, differentiation, and function. Cell Metab. 2011 Oct 5;14(4):478-90. doi: 10.1016/j.cmet.2011.08.010.
Serra L, Montagna P, Mignot E, Lugaresi E, Plazzi G. Cataplexy features in childhood narcolepsy. Mov Disord. 2008 Apr 30;23(6):858-65. doi: 10.1002/mds.21965.
Sicard BA, Perault MC, Enslen M, Chauffard F, Vandel B, Tachon P. The effects of 600 mg of slow release caffeine on mood and alertness. Aviat Space Environ Med. 1996 Sep;67(9):859-62.
Silber MH, Krahn LE, Olson EJ, Pankratz VS. The epidemiology of narcolepsy in Olmsted County, Minnesota: a population-based study. Sleep. 2002 Mar 15;25(2):197-202. doi: 10.1093/sleep/25.2.197.
Thorpy MJ, Krieger AC. Delayed diagnosis of narcolepsy: characterization and impact. Sleep Med. 2014 May;15(5):502-7. doi: 10.1016/j.sleep.2014.01.015. Epub 2014 Feb 15.
Wesensten NJ, Belenky G, Thorne DR, Kautz MA, Balkin TJ. Modafinil vs. caffeine: effects on fatigue during sleep deprivation. Aviat Space Environ Med. 2004 Jun;75(6):520-5.
Wright KP Jr, Badia P, Myers BL, Plenzler SC. Combination of bright light and caffeine as a countermeasure for impaired alertness and performance during extended sleep deprivation. J Sleep Res. 1997 Mar;6(1):26-35. doi: 10.1046/j.1365-2869.1997.00022.x.
Won C, Mahmoudi M, Qin L, Purvis T, Mathur A, Mohsenin V. The impact of gender on timeliness of narcolepsy diagnosis. J Clin Sleep Med. 2014 Jan 15;10(1):89-95. doi: 10.5664/jcsm.3370.
Zhang N, Liu HT. Effects of sleep deprivation on cognitive functions. Neurosci Bull. 2008 Feb;24(1):45-8. doi: 10.1007/s12264-008-0910-z.
Zhang XY, Yu L, Zhuang QX, Zhu JN, Wang JJ. Central functions of the orexinergic system. Neurosci Bull. 2013 Jun;29(3):355-65. doi: 10.1007/s12264-012-1297-4. Epub 2013 Jan 8.
Aldosari MS, Olaish AH, Nashwan SZ, Abulmeaty MMA, BaHammam AS. The effects of caffeine on drowsiness in patients with narcolepsy: a double-blind randomized controlled pilot study. Sleep Breath. 2020 Dec;24(4):1675-1684. doi: 10.1007/s11325-020-02065-6. Epub 2020 Mar 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SFDA # 16022302
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB:E-15-1484
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.