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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN37562266 |
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Date of registration:
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13/04/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effects of Modafinil on functional magnetic resonance imaging (fMRI) brain activation and functional performance during visual stimulation and visually guided tracking manoeuvres after sleep deprivation
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Scientific title:
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Date of first enrolment:
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01/08/2004 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN37562266 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Other)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Robert J.O
Davies |
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Address:
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Consultant in Respiratory Medicine
Oxford Centre for Respiratory Medicine
Churchill Hospital
Headington
OX3 7LJ
Oxford
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 30 Healthy volunteers between the ages of 18-65
Exclusion criteria: Previous neurological disease
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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N/A
Nervous System Diseases
Sleep disorders
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Intervention(s)
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Please note that as of 16/09/09 the status of this trial has been changed to "Stopped" due to relocation of primary investigator (PI) and lack of funding.
Each subject will be scanned 3 times, the first as a baseline, after normal sleep, and then twice after sleep deprivation, following treatment with Modafinil or placebo, in random order. Within each scanning session the subject will perform a series of hand/eye tracking tests of varying difficulty in random order, and a global visual stimulation test. Following the scans objective sleepiness will be quantified from the OSLER test of subjective sleepiness and steering ability will be quantified from the Oxford Steering Simulator. Subjects will be pre-trained to stable performance on the tracking task prior to fMRI scanning.
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Primary Outcome(s)
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The primary endpoint of the trial is the difference in activation of the occipital visual cortex area responsible motion detection (V5/MT) during global visual stimulation after Modafinil and placebo
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Secondary Outcome(s)
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Sleep latency (measured by the OSLER test), driving simulator performance and tracking error will be secondary endpoints
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Source(s) of Monetary Support
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Cephalon UK Ltd (UK) (ref: Davies2004/unrestricted grant)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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