Body Temperature RegulationDragerNCT02017184
Non-invasive Sensor for Core Temperature Measurement
A study testing Noninvasive core temperature thermistor in people with Body Temperature Regulation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Regulation
- What is being tested?
- Noninvasive core temperature thermistor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-25 - healthy
- after medical checkup
- after signing concent form
- with no heat stroke medical history
Who cannot join
- heat stroke medical history
- heart disease
- diabetes
- obesity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center
Tel-Hashomer, Ramat- Gan
Yoram Epstein, PhD, +972544534384, Yoram.Epstein@sheba.health.gov.il
About this study
Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting and walking in thermoneutral and hot environments with two core temperature sensors. The results obtained from them will be compared.
Read the detailed description
During the protocol the volunteers will sit in thermoneutral condition for 30 minutes, than they will sit in hot chamber (40 celsius and 40% relative humidity). Afterwards, the participants will walk on a treadmill in 5 km/hr and 4% incline for one hour. The participants will be connected to rectal thermistor which is considered the "gold standard" and to the new noninvasive sensor which is attached to the skin surface.
- Conditions
- Body Temperature Regulation
- Being tested
- Noninvasive core temperature thermistor
- Keywords
- Body Temperature Regulation Sensor Noninvasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive core temperature thermistorBiological
| Study group | Role | What they receive |
|---|---|---|
| Research arm | Experimental | This trial contains one group which will undergo the described protocol while connected to both sensors: a rectal thermistor and a non invasive thermistor. Receives: Biological: Noninvasive core temperature thermistor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal temperature
The participants will undergo the described protocol and their rectal temperature will be measured by rectal thermistor and the new noninvasive 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: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature RegulationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Barliz Adato, Sheba Medical Center
- Investigators
- Yoram Epstein, PhD, Study director, Heller institute, Sheba medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017184
- Sponsor's protocol ID
- SHEBA-13-0737-BA-CTIL
- Other IDs
- IDF-1233-2013
- Acronym
- Drager
- Status last verified
- Dec 2013
- First submitted
- 16 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Sensor for Core Temperature Measurement
- ClinicalTrials.gov ID
- NCT02017184
- Acronym / sponsor ID
- Drager / SHEBA-13-0737-BA-CTIL
- Conditions
- Body Temperature Regulation
- Keywords
- Body Temperature Regulation Sensor Noninvasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 20 Dec 2013 (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.
Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting and walking in thermoneutral and hot environments with two core temperature sensors. The results obtained from them will be compared.
Detailed description
During the protocol the volunteers will sit in thermoneutral condition for 30 minutes, than they will sit in hot chamber (40 celsius and 40% relative humidity). Afterwards, the participants will walk on a treadmill in 5 km/hr and 4% incline for one hour. The participants will be connected to rectal thermistor which is considered the "gold standard" and to the new noninvasive sensor which is attached to the skin surface.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research arm | Experimental | Biological: Noninvasive core temperature thermistorThis trial contains one group which will undergo the described protocol while connected to both sensors: a rectal thermistor and a non invasive thermistor. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-25 - healthy
- after medical checkup
- after signing concent form
- with no heat stroke medical history
Key exclusion criteria (4 listed)
- heat stroke medical history
- heart disease
- diabetes
- obesity
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 |
|---|---|---|
| Noninvasive core temperature thermistor | Biological | Research arm |
Primary outcome
Rectal temperature
Time frame: 1 year
The participants will undergo the described protocol and their rectal temperature will be measured by rectal thermistor and the new noninvasive thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
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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.
Yoram Epstein, PhD study director
Heller institute, Sheba medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive core temperature thermistor in people with Body Temperature Regulation, 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 4 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 20 Dec 2013. 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 Yoram Epstein, PhD (+972544534384, Yoram.Epstein@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectal temperature (time frame: 1 year). 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 20 Dec 2013.