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The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
partial and complete sleep deprivation
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Deprivation focused on measuring sleep, HTT, heat illness

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Heller Institute of Medical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sleep deprivation

Arm Description

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.

Outcomes

Primary Outcome Measures

oxygen consumption
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
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
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
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).

Full Information

First Posted
May 6, 2012
Last Updated
May 8, 2014
Sponsor
Sheba Medical Center
Collaborators
International Diabetes Federation
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1. Study Identification

Unique Protocol Identification Number
NCT01596543
Brief Title
The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
Official Title
Thr Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
International Diabetes Federation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
sleep, HTT, heat illness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sleep deprivation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
partial and complete sleep deprivation
Intervention Description
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.
Primary Outcome Measure Information:
Title
oxygen consumption
Description
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.
Time Frame
experimental days 1,3,4
Secondary Outcome Measure Information:
Title
Skin temperature
Description
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.
Time Frame
experimental days 2,3,4
Title
Rectal temperature
Description
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.
Time Frame
experimental days 2,3,4
Title
Heart rate
Description
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).
Time Frame
experimental days 1,2,3,4

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Druyan, M.D
Organizational Affiliation
The Institute of Military Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heller Institute of Medical Research
City
Tel-Hashomer, Ramat-Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
25955404
Citation
Muginshtein-Simkovitch E, Dagan Y, Cohen-Zion M, Waissengrin B, Ketko I, Heled Y. Heat tolerance after total and partial acute sleep deprivation. Chronobiol Int. 2015 Jun;32(5):717-24. doi: 10.3109/07420528.2015.1030409. Epub 2015 May 8.
Results Reference
derived

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The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance

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