NCT01596543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

May 6, 2012

Last Update Submit

May 8, 2014

Conditions

Keywords

sleepHTTheat illness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Skin temperature

    experimental days 2,3,4

  • Rectal temperature

    experimental days 2,3,4

  • Heart rate

    experimental days 1,2,3,4

Study Arms (1)

sleep deprivation

EXPERIMENTAL

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

Interventions

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.

sleep deprivation

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-30
  • healthy
  • after medical checkup
  • after signing concent form

You may not qualify if:

  • heart disease
  • respiratory disease
  • baseline bp above 140/90 mmHg
  • sleep disorders
  • diabetes
  • anhydrosis
  • skin disease
  • acute illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heller Institute of Medical Research

Tel-Hashomer, Ramat-Gan, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep DeprivationHeat Stress Disorders

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersWounds and Injuries

Study Officials

  • Amit Druyan, M.D

    The Institute of Military Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2012

First Posted

May 11, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations