The Effect of Caffeine on the Narcoleptic Patients

NCT02832336 | Completed Phase 1 DMC

• 2 other identifiers: IRB:E-15-1484SFDA # 16022302
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Narcolepsy

Keywords

Caffeine; Caffeine citrate; Neurological disorder; Excessive daytime sleepiness; Orexin; adenosine antagonist

Outcome Measures

Primary Outcomes (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).

  7 days

Secondary Outcomes (2)

• Stanford Sleepiness Scale (SSS)

  7 days

• The Karolinska Sleepiness Scale (KSS)

  7 days

Study Arms (2)

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.

Drug: Vivarin

Fiber

PLACEBO COMPARATOR

Fiber powder will be used as placebo, Form of Administration:Oral in veg white capsule form (size 1)

Drug: Fiber

Interventions

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.

Also known as: 1,3,7-Trimethylpurine-2,6-dione, C8H10N4O2, caffeine citrate

Caffeine

Fiber DRUG

Fiber will be used as placebo.

Also known as: Nutrisource Fiber

Fiber

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Case -group should be Narcoleptic with cataplexy

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead
• King Saud Medical City: collaborator

Study Sites (1)

King Khalid University Hospital:King Saud Medical City

Riyadh, Saudi Arabia

Location

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MeSH Terms

Conditions

Narcolepsy; Nervous System Diseases; Disorders of Excessive Somnolence

Interventions

Caffeine; caffeine citrate; Dietary Fiber

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mona S Aldosari, Masteral

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: July 14, 2016
• Study Start: October 1, 2016
• Primary Completion: May 11, 2017
• Study Completion: May 7, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

SA (1)