Body Temperature RegulationDrägerNCT02691832
Measuring Core Body Temperature Using a Novel Non-invasive Sensor
A study testing "Dräger" double sensor in people with Body Temperature Regulation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. 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
- Body Temperature Regulation
- What is being tested?
- "Dräger" double sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to Aug 2017
- 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
- Aged 18-40 years.
- Healthy civilian volunteers.
- Without known medical illness or medication use.
Who cannot join
- History of heat injury.
- The existence or suspicion of existing cardiac or respiratory disease.
- Diabetes.
- Obesity.
- Infectious disease 3 days prior to the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study
The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.
Read the detailed description
12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.
- Conditions
- Body Temperature Regulation
- Being tested
- "Dräger" double sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Dräger" double sensorDevice
The "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature.
| Study group | Role | What they receive |
|---|---|---|
| research arm | Experimental | the trial contains one group which will undergo the described protocol three times:
1. connected to rectal thermistor and to the double sensor
2. connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd.
3. connected to rectal thermistor and to the double sensor integrated into a helmet. Receives: Device: "Dräger" double sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double sensor temperature
the Double Sensor will be attached to the forehead by sticker or integrated into a helmet. Double sensor temperature will be monitored continuously.
Measured: 3 days for each participant
rectal temperature
rectal thermistor is the "gold standard" for core body temperature and will be measured continuously.
Measured: 3 days for each participant
Secondary outcomes (2)
heart rate
heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Measured: 4 days for each participant
skin temperature
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Measured: 3 days for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (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
- Diagnosis
- 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
- Sponsor
- Investigators
- Haggai Schermann, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691832
- Sponsor's protocol ID
- SHEBA-16-2920-HS-CTIL
- Acronym
- Dräger
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study
- ClinicalTrials.gov ID
- NCT02691832
- Acronym / sponsor ID
- Dräger / SHEBA-16-2920-HS-CTIL
- Conditions
- Body Temperature Regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 Feb 2016 (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 Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.
Detailed description
12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research arm | Experimental | Device: "Dräger" double sensorthe trial contains one group which will undergo the described protocol three times: 1. connected to rectal thermistor and to the double sensor 2. connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd. 3. connected to rectal thermistor and to the double sensor integrated into a helmet. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-40 years.
- Healthy civilian volunteers.
- Without known medical illness or medication use.
Key exclusion criteria (5 listed)
- History of heat injury.
- The existence or suspicion of existing cardiac or respiratory disease.
- Diabetes.
- Obesity.
- 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 |
|---|---|---|
| "Dräger" double sensorThe "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature. | Device | research arm |
Primary outcome
Double sensor temperature
Time frame: 3 days for each participant
the Double Sensor will be attached to the forehead by sticker or integrated into a helmet. Double sensor temperature will be monitored continuously.
rectal temperature
Time frame: 3 days for each participant
rectal thermistor is the "gold standard" for core body temperature and will be measured continuously.
2 secondary outcomes
heart rate
Time frame: 4 days for each participant
skin temperature
Time frame: 3 days for each participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Haggai Schermann, M.D principal investigator
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 "Dräger" double sensor 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 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 25 Feb 2016. 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 Haggai Schermann, M.D (+972828771014, Haggai.Schermann@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double sensor temperature (time frame: 3 days for each participant). The study lists 2 primary outcomes in all. 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 25 Feb 2016.