- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01596543
The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
May 8, 2014 updated by: Sheba Medical Center
Thr Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
The purpose of the present study is to evaluate the effect of partial and complete sleep deprivation on exercise heat tolerance.
Twelve healthy young male volunteers will participate in the study.
They will arrive to our lab four times, in each visit the will undergo VO2 test and Heat Tolerance Test (HTT) after sleeping different amount of hours.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The volunteers will arrive to our lab fout times- During their first visit they will go through a VO2 max test in order to evaluate their aerobic fitness, and their physiological efficiency will be measured.
During their second visit they will go through an exercise heat tolerance test according to our validated protocol after a full night sleep.
During the third and fourth visit they will go through an exercise heat tolerance test and a measurement of their physiological efficiency after a partial and complete sleep deprivation, respectively.
The physiological tests will take place in the heat chamber that is located at the Heller Institute of Medical Research.
The results will be then analyzed, and a comparison between the physiological measurements during the heat tolerance tests and the physiological efficiency tests after the various sleep conditions will be performed.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel-Hashomer, Ramat-Gan, Israel
- Heller Institute of Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- age 18-30
- healthy
- after medical checkup
- after signing concent form
Exclusion Criteria:
- heart disease
- respiratory disease
- baseline bp above 140/90 mmHg
- sleep disorders
- diabetes
- anhydrosis
- skin disease
- acute illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sleep deprivation
The research contains only one arm.
The subjects will be tested with no sleep deprivation (which will be used as a control measurement) and with partial and complete sleep deprivation.
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The subjects will visit our labs 4 times.
The second visit will be used as the experimental control.
During the third and fourth visits the subject will go through an exercise heat tolerance test and a measurement of their physiological efficiency after a partial and complete sleep deprivation, respectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oxygen consumption
Time Frame: experimental days 1,3,4
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volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.Each volunteer will undergo the test 4 times.
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experimental days 1,3,4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin temperature
Time Frame: experimental days 2,3,4
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The volunteers will undergo Heat Tolerance Test (HTT).
Their skin temperature will be measured by skin thermistors and will be monitored continuously and viewed by the attending medical staff.
Automatically all data will be recorded by the monitoring Biopac system.
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experimental days 2,3,4
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Rectal temperature
Time Frame: experimental days 2,3,4
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The volunteers will undergo heat tolerance test.
Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff.
Automatically all data will be recorded by the monitoring Biopac system.
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experimental days 2,3,4
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Heart rate
Time Frame: experimental days 1,2,3,4
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During the HTT (Heat Tolerance Test) and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
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experimental days 1,2,3,4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amit Druyan, M.D, The Institute of Military Physiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
May 6, 2012
First Submitted That Met QC Criteria
May 9, 2012
First Posted (Estimate)
May 11, 2012
Study Record Updates
Last Update Posted (Estimate)
May 9, 2014
Last Update Submitted That Met QC Criteria
May 8, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-11-8728-AD-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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