The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance

Sleep Deprivation Clinical Trial

Official title:

Thr Effect of Partial and Complete Sleep Deprivation on Heat Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596543
• Other study ID #: SHEBA-11-8728-AD-CTIL
• Status: Completed
• Phase: N/A
• First received: May 6, 2012
• Last updated: May 8, 2014
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

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.

Locations

Country	Name	City	State
Israel	Heller Institute of Medical Research	Tel-Hashomer, Ramat-Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	International Diabetes Federation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	experimental days 1,3,4	No
Secondary	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.	experimental days 2,3,4	No
Secondary	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.	experimental days 2,3,4	Yes
Secondary	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).	experimental days 1,2,3,4	Yes