Physiological StrainNCT01595906
The Affect of a Ventilated Helmet on Physiological Load
A study testing Ventilated Helmet in people with Physiological Strain, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
The use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. Read more about this study
- Who is it for?
- Ages 21 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiological Strain
- What is being tested?
- Ventilated Helmet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Feb 2013
- 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 21 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy civilian volunteers
- aged 21-28
- without known medical illnesses or medication use
Who cannot join
- the existence of or suspicion of existing cardiac or respiratory disease
- hypertension
- diabetes
- any hormonal disease or any other chronic illness that may inhibit participation in the experiment
- infectious disease 3 days prior to the experiment.
Trial locations and contacts
1 site in 1 country.
Amit Druyan, M.D contact
Israel1 site
Heller insitute, Sheba hospital
Ramat Gan
Amit Druyan, M.D, Amit.Druyan@sheba.health.gov.il
About this study
Official title: The Affect of a Ventilated Helmet System on Human Physiological Load
The use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. An improvement in function may also be possible.The purpose of this research is to determine the extent of the cognitive and physiological strain caused by wearing a helmet under exertional conditions while exposed to heavy heat stress and to evaluate the effect of a unique ventilation system connected to the helmet on strain reduction.
Read the detailed description
12 young, healthy civilian volunteers, aged 21-28 will participate in the study. Following a day of examinations and 6 days of acclimatization in a climatic chamber in accordance with a well accepted protocol, the subjects will undergo 3 days of experiment that will include exposure to hot environmental conditions with different helmet-wearing scenarios, while wearing uniform and a combat vest: (a) without a helmet (b) with a helmet (c) with a helmet connected to a ventilation system. All 3 scenarios will include a two hour effort (walking on a treadmill) in heavy heat stress in the climatic chamber at our institute (the Heller institute of medical research).
- Conditions
- Physiological Strain
- Being tested
- Ventilated Helmet
- Keywords
- Helmet, Heat Tolerance Test, ventilation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilated HelmetProcedure or surgery
The ventilation system is installed on the inner part of the helmet and connected to a bellows and an energy source placed on the vest worn by the soldier. The system's working principal is based on air perfusion with a small ventilator.
| Study group | Role | What they receive |
|---|---|---|
| The experiment subjects | Experimental | The subjects will undergo:
1. 6 acclimatization days carried out by a standard protocol including a daily 2 hour effort performed in a climatic chamber, during which the subjects walk on a treadmill at 5km/h on a 2% incline under heat conditions (40 deg. centigrade \& 40% RH). Core (rectal) and skin temperatures and heart rate will be monitored continuously.
2. Three consecutive days including 3 scenarios:
1. Without a helmet b.With a helmet c.With a ventilated helmet During the experiment days the subjects will be exposed to the following protocol : A 5 minute sitting, performing cognitive tests on a computer for 15 min, 120 min walking on a treadmill at 5km/h on a 2% incline, at the end of the effort the same cognitive tests will be repeated for extra 15 min, 155 min in total. Receives: Procedure: Ventilated Helmet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological strain
The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test(HTT).
Measured: 9 days
Secondary outcomes (4)
Rectal temperature
The Rectal temperature will be mesured by a rectal thermistore during each HTT
Measured: 9 days
Skin temperature
The Skin temperature will be mesured by skin thermistores on 4 sites (chest, leg and arm and head).
Measured: 9 days
Heart Rate
Heart rate will be monitored using a polar watch.
Measured: 9 days
Sweat Rate
Sweat rate will be calculated from the patient's weight and his water balance
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StrainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Druyan, M.D, Principal investigator, IDF medical corps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595906
- Sponsor's protocol ID
- 1037-2011-IDF-CTIL
- Status last verified
- May 2012
- First submitted
- 22 Mar 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of a Ventilated Helmet System on Human Physiological Load
- ClinicalTrials.gov ID
- NCT01595906
- Acronym / sponsor ID
- 1037-2011-IDF-CTIL
- Conditions
- Physiological Strain
- Keywords
- Helmet, Heat Tolerance Test, ventilation System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 10 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 use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. An improvement in function may also be possible.The purpose of this research is to determine the extent of the cognitive and physiological strain caused by wearing a helmet under exertional conditions while exposed to heavy heat stress and to evaluate the effect of a unique ventilation system connected to the helmet on strain reduction.
Detailed description
12 young, healthy civilian volunteers, aged 21-28 will participate in the study. Following a day of examinations and 6 days of acclimatization in a climatic chamber in accordance with a well accepted protocol, the subjects will undergo 3 days of experiment that will include exposure to hot environmental conditions with different helmet-wearing scenarios, while wearing uniform and a combat vest: (a) without a helmet (b) with a helmet (c) with a helmet connected to a ventilation system. All 3 scenarios will include a two hour effort (walking on a treadmill) in heavy heat stress in the climatic chamber at our institute (the Heller institute of medical research).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The experiment subjects | Experimental | Procedure: Ventilated HelmetThe subjects will undergo: 1. 6 acclimatization days carried out by a standard protocol including a daily 2 hour effort performed in a climatic chamber, during which the subjects walk on a treadmill at 5km/h on a 2% incline under heat conditions (40 deg. centigrade \& 40% RH). Core (rectal) and skin temperatures and heart rate will be monitored continuously. 2. Three consecutive days including 3 scenarios: 1. Without a helmet b.With a helmet c.With a ventilated helmet During the experiment days the subjects will be exposed to the following protocol : A 5 minute sitting, performing cognitive tests on a computer for 15 min, 120 min walking on a treadmill at 5km/h on a 2% incline, at the end of the effort the same cognitive tests will be repeated for extra 15 min, 155 min in total. |
Who may qualify
- Ages
- 21 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy civilian volunteers
- aged 21-28
- without known medical illnesses or medication use
Key exclusion criteria (5 listed)
- the existence of or suspicion of existing cardiac or respiratory disease
- hypertension
- diabetes
- any hormonal disease or any other chronic illness that may inhibit participation in the experiment
- infectious disease 3 days prior to the experiment.
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 |
|---|---|---|
| Ventilated HelmetThe ventilation system is installed on the inner part of the helmet and connected to a bellows and an energy source placed on the vest worn by the soldier. The system's working principal is based on air perfusion with a small ventilator. | Procedure or surgery | The experiment subjects |
Primary outcome
Physiological strain
Time frame: 9 days
The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test(HTT).
4 secondary outcomes
Rectal temperature
Time frame: 9 days
Skin temperature
Time frame: 9 days
Heart Rate
Time frame: 9 days
Sweat Rate
Time frame: 9 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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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 contact
Amit Druyan, M.D principal investigator
IDF medical corps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilated Helmet in people with Physiological Strain, run by Medical Corps, Israel Defense Force 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 May 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Druyan, M.D (Amit.Druyan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological strain (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2012.