Condition category
Mental and Behavioural Disorders
Date applied
04/08/2011
Date assigned
26/08/2011
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims?
Studies have repeatedly shown that modafinil, a drug that promotes alertness, is capable of reversing some of the effects of sleep deprivation. This study aim to assess the impact of modafinil on the thinking skills and hand-eye coordination of a small group of sleep deprived doctors.

Who can take part?
Male training grade doctors working within or affiliated to Imperial College Healthcare NHS Trust. Participants must be healthy and medication free. Specifically, individuals with a history of neurological illness, heart problems, breathing difficulties, substance misuse or psychiatric illness will not be eligible to take part.

What does the study involve?
All participants will undergo a period of skills training following which they will attend the study centre for one night of supervised sleep deprivation. Participants will be randomly allocated to receive either modafinil or placebo at 3am and will undergo a series of laboratory based tests of thinking and hand-eye coordination between 6am and approximately 8am. Doctors will be advised not to return to their clinical work for 48hrs following conclusion of the study.

What are the possible benefits and risks of taking part?
Participants can expect to learn basic technical skills relevant to surgical training. There are no other benefits to the participant form taking part in the study.
Possible side effects of modafinil include: neurological side effects such as headache and dizziness, cardiovascular side effects such as fast heart beat and palpitations, respiratory side effects such as cough and wheeze and gastrointestinal side effects such as dry mouth and bowel disturbance. A more detailed description of the drug and list of side effects is available at patient.co.uk: http://www.patient.co.uk/medicine/Modafinil.htm.

Where is the study run from?
The study will be run from Imperial College London, Department of Surgery and Cancer, St Mary’s Hospital Campus.

When is the study starting and how long is it expected to run for?
August 2009 to March 2010

Who is funding the study?
Imperial College London, Department of Surgery and Cancer.

Who is the main contact?
Dr Colin Sugden (Academic Clinical Lecturer)
c.sugden@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colin Sugden

ORCID ID

Contact details

Imperial College London and Imperial College Healthcare NHS Trust
St Mary's Hospital
Praed Street
Paddington
London
W2 1NY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/CD/008

Study information

Scientific title

Can modulation of neurochemical pathways in the brain reverse the effects of sleep deprivation on the psychomotor and cognitive performance of surgical trainees?

Acronym

RESD

Study hypothesis

Modafinil is a well tolerated and effective pharmacological wakefulness promoting agent. We hypothesise that modafinil administration will improve the cognitive and clinical psychomotor performance of a cohort of acutely sleep deprived doctors.

Ethics approval

Cambridgeshire 1 Research Ethics Committee approved on 22 June 2009, ref: 09/H0304/24

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neuropsychopharmacology, sleep deprivation, medical simulation

Intervention

1. Modafinil 200mg
2. Single administration per subject

Intervention type

Drug

Phase

Not Applicable

Drug names

Modafinil

Primary outcome measures

1. Cognitive performance assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) battery of neuropsychological tests
2. Clinical psychomotor performance assessed using the MIST-VR simulator

Secondary outcome measures

1. Subjective rating of fatigue - Stanford Scale and Visual Analogue Scale
2. Heart rate & blood pressure monitoring

Overall trial start date

01/08/2009

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy male resident doctors taking no regular medication and with experience of less than 10 laparoscopic cases as primary operator

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

40

Participant exclusion criteria

1. History of psychiatric illness
2. Visual, auditory or motor impairment
3. Cardiac or neurological illness
4. Score of greater than 10 on the Epworth Sleepiness Scale
5. More than two positive responses to the CAGE questionnaire
6. History of drug or alcohol addiction
7. Consumption of more than eight cups of coffee per day

Recruitment start date

01/08/2009

Recruitment end date

01/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London and Imperial College Healthcare NHS Trust
London
W2 1NY
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

St Mary's Hospital
Praed Street
Paddington
London
W2 1NY
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

University/education

Funder name

Department of Surgery & Cancer, Imperial College London (UK)

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes