Reversing the Effects of Sleep Deprivation (RESD)
| ISRCTN | ISRCTN44899331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44899331 |
| Secondary identifying numbers | 08/CD/008 |
- Submission date
- 04/08/2011
- Registration date
- 26/08/2011
- Last edited
- 13/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 Marys 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
Contact information
Scientific
Imperial College London and Imperial College Healthcare NHS Trust
St Mary's Hospital
Praed Street
Paddington
London
W2 1NY
United Kingdom
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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? |
| Study acronym | RESD |
| Study objectives | 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(s) | Cambridgeshire 1 Research Ethics Committee, 22/06/2009, ref: 09/H0304/24 |
| Health condition(s) or problem(s) studied | Neuropsychopharmacology, sleep deprivation, medical simulation |
| Intervention | 1. Modafinil 200mg 2. Single administration per subject |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Modafinil |
| Primary outcome measure | 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 study start date | 01/08/2009 |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 40 |
| Key inclusion criteria | Healthy male resident doctors taking no regular medication and with experience of less than 10 laparoscopic cases as primary operator |
| Key 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 |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W2 1NY
United Kingdom
Sponsor information
University/education
St Mary's Hospital
Praed Street
Paddington
London
W2 1NY
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2012 | Yes | No |
Editorial Notes
13/03/2018: Publication reference added.
13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
