Sleep DeprivationNCT01596543
The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
A study testing partial and complete sleep deprivation in people with Sleep Deprivation, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- partial and complete sleep deprivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-30
- healthy
- after medical checkup
- after signing concent form
Who cannot join
- heart disease
- respiratory disease
- baseline bp above 140/90 mmHg
- sleep disorders
- diabetes
- anhydrosis
- skin disease
- acute illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- partial and complete sleep deprivation
- Keywords
- sleep, HTT, heat illness
- Medical subject headings
- Sleep Deprivation, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial and complete sleep deprivationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: partial and complete sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: experimental days 1,3,4
Secondary outcomes (3)
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.
Measured: experimental days 2,3,4
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.
Measured: experimental days 2,3,4
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).
Measured: experimental days 1,2,3,4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- International Diabetes Federation
- Responsible party
- Sponsor
- Investigators
- Amit Druyan, M.D, Principal investigator, The Institute of Military Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596543
- Sponsor's protocol ID
- SHEBA-11-8728-AD-CTIL
- Status last verified
- May 2014
- First submitted
- 6 May 2012
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25955404
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thr Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
- ClinicalTrials.gov ID
- NCT01596543
- Acronym / sponsor ID
- SHEBA-11-8728-AD-CTIL
- Conditions
- Sleep Deprivation
- Keywords
- sleep, HTT, heat illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- International Diabetes Federation
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sleep deprivation | Experimental | Other: partial and complete sleep deprivationThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-30
- healthy
- after medical checkup
- after signing concent form
Key exclusion criteria (8 listed)
- heart disease
- respiratory disease
- baseline bp above 140/90 mmHg
- sleep disorders
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| partial and complete sleep deprivationThe 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. | Other | sleep deprivation |
Primary outcome
oxygen consumption
Time frame: experimental days 1,3,4
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.
3 secondary outcomes
Skin temperature
Time frame: experimental days 2,3,4
Rectal temperature
Time frame: experimental days 2,3,4
Heart rate
Time frame: experimental days 1,2,3,4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Derived from this study: PubMed 25955404Muginshtein-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Druyan, M.D principal investigator
The Institute of Military Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial and complete sleep deprivation in people with Sleep Deprivation, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen consumption (time frame: experimental days 1,3,4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.