The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance

This study has been completed.
Sponsor:
Collaborator:
International Diabetes Federation
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01596543
First received: May 6, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Sleep Deprivation
Other: partial and complete sleep deprivation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Thr Effect of Partial and Complete Sleep Deprivation on Heat Tolerance

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • oxygen consumption [ Time Frame: experimental days 1,3,4 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Skin temperature [ Time Frame: experimental days 2,3,4 ] [ Designated as safety issue: No ]
    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.

  • Rectal temperature [ Time Frame: experimental days 2,3,4 ] [ Designated as safety issue: Yes ]
    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.

  • Heart rate [ Time Frame: experimental days 1,2,3,4 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 12
Study Start Date: November 2012
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: partial and complete sleep deprivation
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596543

Locations
Israel
Heller Institute of Medical Research
Tel-Hashomer, Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
International Diabetes Federation
Investigators
Principal Investigator: Amit Druyan, M.D The Institute of Military Physiology
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01596543     History of Changes
Other Study ID Numbers: SHEBA-11-8728-AD-CTIL
Study First Received: May 6, 2012
Last Updated: May 8, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
sleep
HTT
heat illness

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014