UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015219 |
|---|---|
| Receipt number | R000017695 |
| Scientific Title | Can Modulation of neurochemical pathways in the brain reverse the effects of sleep deprivation on the psychmotor and cognitive performance of surgical trainees 09/H0304/24 amendment 5(REC6) |
| Date of disclosure of the study information | 2014/09/22 |
| Last modified on | 2014/09/21 21:09:28 |
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Basic information
Public title
Can Modulation of neurochemical pathways in the brain reverse the effects of sleep deprivation on the psychmotor and cognitive performance of surgical trainees 09/H0304/24 amendment 5(REC6)
Acronym
The Preservation of Cued Recall in the Acute Mentally Fatigued State- A Randomised Crossover Study
Scientific Title
Can Modulation of neurochemical pathways in the brain reverse the effects of sleep deprivation on the psychmotor and cognitive performance of surgical trainees 09/H0304/24 amendment 5(REC6)
Scientific Title:Acronym
The Preservation of Cued Recall in the Acute Mentally Fatigued State- A Randomised Crossover Study
Region
| Europe |
Condition
Condition
A randomised crossover study involving twenty healthy medical students assessed free (presentation) and cued (MCQ) recall of clinical case histories at 0 and 2hrs under low and high cognitive load settings using the N-Back task.
Classification by specialty
| Medicine in general | Surgery in general | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of acute mental fatigue on the recall of clinical information in the non-sleep deprived state.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Free Recall
Cued Recall
Key secondary outcomes
N-Back task
Visual analogue scale
Stanford Scale
NASA TLX
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Day 1 N-Back task - visual 1-back for 15 minutes alternating with 15 minutes rest time for 90 minutes. (control). Using History 1
Day 2 N-Back task - dual 2 back (visual and audio) for 90 minutes Using History 2
Interventions/Control_2
Day 1 N-Back task - dual 2 back (visual and audio) for 90 minutes Using History 1
Day 2 N-Back task - visual 1-back for 15 minutes alternating with 15 minutes rest time for 90 minutes. (control). Using History 2
Interventions/Control_3
Day 1 N-Back task - visual 1-back for 15 minutes alternating with 15 minutes rest time for 90 minutes. (control). Using History 2
Day 2 N-Back task - dual 2 back (visual and audio) for 90 minutes Using History 1
Interventions/Control_4
Day 1 N-Back task - dual 2 back (visual and audio) for 90 minutes Using History 2
Day 2 N-Back task - visual 1-back for 15 minutes alternating with 15 minutes rest time for 90 minutes. (control). Using History 1
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy medical students with experience of presenting clinical histories.
Stimulant (caffeine) free from midnight
No regular medications
Key exclusion criteria
Caffeine based products, chocolate or medications that would effect cognitive state.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ara Darzi |
Organization
Imperial College
Division name
Department of BioSurgery and Surgical Technology
Zip code
Address
St Mary's Hospital London W21NY
TEL
442033126666
a.darzi@imperial.ac.uk
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ara Darzi |
Organization
Imperial College London
Division name
Department of BioSurgery and Surgical Technology
Zip code
Address
St Mary's Hospital London W21NY
TEL
442033126666
Homepage URL
a.darzi@imperial.ac.uk
Sponsor or person
Institute
Imperial College London
Institute
Department
Personal name
Funding Source
Organization
Imperial College London
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
UK
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Imperial College London
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Free recall is significantly impaired by increased cognitive load (p<0.05) with subjects demonstrating perceived mental fatigue during the high cognitive load assessment. There was no significant difference in the amount of information retrieved by cued recall under high and low cognitive load conditions (p =1).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 21 | Day |
Last modified on
| 2014 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017695
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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