Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
C03.056
Study information
Scientific title
Acronym
Modafinil Study
Study hypothesis
Therefore we wish to examine brain activity and performance during hand/eye tracking manoeuvres, (as quantified by fMRI and our tracking tasks), in normal subjects before and after total sleep deprivation following treatment with Modafinil or placebo. We will compare whether the Modafinil has reversed the effects of the sleep deprivation, compared to placebo
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Other
Patient information sheet
Condition
N/A
Intervention
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.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Modafinil
Primary outcome measure
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
Secondary outcome measures
Sleep latency (measured by the OSLER test), driving simulator performance and tracking error will be secondary endpoints
Overall study start date
01/08/2004
Overall study end date
30/06/2006
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
30 Healthy volunteers between the ages of 18-65
Participant type(s)
Healthy volunteer
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
Both
Target number of participants
30
Participant exclusion criteria
Previous neurological disease
Recruitment start date
01/08/2004
Recruitment end date
30/06/2006
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Consultant in Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
Oxford Radcliffe Hospitals NHS Trust (UK)
Sponsor details
University of Oxford (NDM)
Level 5
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Industry
Funder name
Cephalon UK Ltd (UK) (ref: Davies2004/unrestricted grant)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|