Body Temperature ChangesNCT02226614
Development of a Head Cooling Device
A study testing University of Edinburgh head cooling device in people with Body Temperature Changes, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study is testing a head-cooling device on volunteers to assess temperature reduction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- University of Edinburgh head cooling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Feb 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy humans
Who cannot join
- pregnant
- refusal of consent for registration with The Over-volunteering Protection Scheme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Head-cooling Device for Brain Injury: Healthy Volunteer Study
This study is testing a head-cooling device on volunteers to assess temperature reduction.
- Conditions
- Body Temperature Changes
- Being tested
- University of Edinburgh head cooling device
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
University of Edinburgh head cooling deviceDevice
head cooling
| Study group | Role | What they receive |
|---|---|---|
| head cooling | Experimental | head cooling Receives: Device: University of Edinburgh head cooling device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature change
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Andrews, MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226614
- Sponsor's protocol ID
- vs1 25.03.14
- Status last verified
- Dec 2015
- First submitted
- 22 Jul 2014
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Head-cooling Device for Brain Injury: Healthy Volunteer Study
- ClinicalTrials.gov ID
- NCT02226614
- Acronym / sponsor ID
- vs1 25.03.14
- Conditions
- Body Temperature Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Aug 2014 (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.
This study is testing a head-cooling device on volunteers to assess temperature reduction.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head cooling | Experimental | Device: University of Edinburgh head cooling devicehead cooling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy humans
Key exclusion criteria (2 listed)
- pregnant
- refusal of consent for registration with The Over-volunteering Protection Scheme
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 |
|---|---|---|
| University of Edinburgh head cooling devicehead cooling | Device | head cooling |
Primary outcome
Temperature change
Time frame: 6 hours
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 15 Jun 2016.
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Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
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Progressive Heat Exposure and Physiological Strain
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Enrolling by invitation
Exercise Intensity and Heat Responses in Children and Youth
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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.
Peter Andrews, MD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing University of Edinburgh head cooling device in people with Body Temperature Changes, run by University of Edinburgh at 1 site in United Kingdom.
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 1 inclusion and 2 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 15 Jun 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 United Kingdom. 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?
Temperature change (time frame: 6 hours). 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 Jun 2016; AzTrials last refreshed its copy on 30 Oct 2026.