Core Body TemperatureNCT02340377
Pill Study Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology
An observational study of Core Body Temperature, run by University of Arizona at 1 site in United States.
Trial summary
The primary objective of the proposed study is to determine the use of a wireless method to monitor and record core body temperature during a Whole Body Hyperthermia treatment, compared to an indwelling rectal thermometer. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Core Body Temperature
- What is being tested?
- ELITE 3 HQ
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2015
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: For the purposes of this study we will enroll subjects 18-50 years of age to undergo a Hyperthermia session in an open fashion. We expect approximately 20 - 30 subjects to undergo this open hyperthermia treatment. Subjects must be medically healthy enough to be able to undergo the Hyperthermia session, all exclusion criteria listed below address what is deemed "medically healthy", per self-report by potential subjects. There will be no inclusion of children, pregnant women, mentally impaired individuals, or prisoners in this study.
Who may be able to join
- Male or females aged 18-50 years.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Able to communicate in English with study personnel.
- For women of child-bearing potential (i.e., one who is biologically capable of become pregnant,) must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial per self-report.
Who cannot join
- Any of the following diagnoses, as identified by the psychiatric evaluation or study assessments:
- A current DSM-IV-TR Axis I diagnosis of Dementia; or
- Any current DSM-IV-TR Axis II diagnosis (i.e. personality disorder) that would suggest potential noncompliance with the protocol; or
- A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Type 1; or
- A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
- A current (or within 6 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
Show all 29Show fewer
- Individuals with psychiatric diagnoses may be excluded per the investigator's discretion.
- If patient has a medical condition or disorder that:
- Is unstable and clinically significant, or:
- Could, in the investigator's opinion, interfere with the accurate assessment of safety or efficacy of the procedure, including:
- individuals who are using prescription drugs that may impair thermoregulatory cooling,
- individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
- individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
- individuals with a fever the day of study intervention (if so, they will be rescheduled),
- individuals with hypersensitivity to heat,
- individuals with enclosed infections, be they dental, in joints, or in any other tissues,
- Use of any psychotropic medications for 2 weeks (8 weeks for fluoxetine) prior to initiation of the study, with the exception of a stable dosage of benzodiazepine or non-benzodiazepine hypnotic medications (e.g. zolpidem (Ambien), zaleplon (Sonata), eszopiclone (Lunesta), lorazepam (Ativan), diazepam (Valium), clonazepam (Klonopin), alprazolam (Xanax),
- Women who are pregnant (HCG pregnancy test at screening, or lactating, or who plan to become pregnant during the study.
- Reasonable likelihood for non-compliance with the protocol for any other reason, in the opinion of the Investigator, prohibits enrollment of subject into the study.
- Obesity and overall size of subject. It will be up to the PI's discretion will consider BMI, waist circumference, and body fat composition when determining eligibility and safety of the individual.
- History of peripheral circulatory disease, for example peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
- History of a cerebral vascular accident
- History of stroke, epilepsy or cerebral aneurisms
- Cancer in the last five years, except for fully resected non-melanoma skin cancer.
- Diabetes mellitus types I or II.
- Any clinically significant autoimmune disease (compensated hypothyroidism and fibromyalgia allowed)
- Active alcohol/drug abuse in 2 weeks prior to screening for those who have been dependent or have abused on drugs/alcohol in the last 2 months (with the exception of marijuana use).
- Individuals with a history of having difficulty swallowing food or large capsules will be excluded from participating in the assessment of core body temperature (because swallowing a large sensor pill is required). The indigestible temperature capsules will not be used in subjects with any known or suspected obstructive disease of the gastrointestinal tract including, but not limited to esophageal stricture, diverticulosis and inflammatory bowel disease (IBD), peptic ulcer disease, Crohn's disease, ulcerative colitis; previous gastrointestinal surgery.
- Individuals who have experience with cognitive enhancing programs such as Luminosity, Cogmed or Elevate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Core Body Temperature During Hyperthermia in a Whole Body Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology
The primary objective of the proposed study is to determine the use of a wireless method to monitor and record core body temperature during a Whole Body Hyperthermia treatment, compared to an indwelling rectal thermometer.
This protocol is intended to study the differences between a rectal temperature probe and an approved wireless and indigestible thermometer during a WBH session. The current standard in monitoring core body temperature is the usage of an indwelling rectal thermometer. Many patients and potential study subjects, however, decline receiving the treatment, due to the discomfort of using this measuring method and a wireless measuring device would open the possibility for those patients to receive a treatment. The primary endpoint for example of a treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C. However, due to the proximity of the probe to the body's surface, the core body temperature will vary from the rectal temperature and the comparison between the two methods with a validation of the wireless device is necessary.
The investigators will monitor subject's physiological outcome from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This study will include safety assessments 7 days several days prior to or same day as the WBH, and include follow-up assessments 1 day and 1 week later.
Read the detailed description
This protocol will allow for the evaluation of a wireless measuring device for core body temperature and a comparison to the data taken with a rectal thermometer, during a Whole Body Hyperthermia (WBH) in various subject populations. The primary objective of the proposed study is a potential change from wired core body temperature measurement with a rectal thermometer to an indigestible thermometer with wireless technology.
The recent standard for measuring core body temperature during WBH procedures is the use of an indwelling rectal thermometer to constantly monitor the temperature for safety and for research reasons. Experiences from different clinics and research groups, including ours, show a high drop-out rate of potential study participants and patients, because of the discomfort of self-inserting a rectal thermometer for the treatment in a Whole-Body Hyperthermia. A wireless and reliable measuring technology would open this treatment for participants, who are declining their participation due to the indwelling thermometer. This device will exit the subject's body via bowel movement 1-5 days following ingestion and will not be reused.
Due to the proximity of the indwelling thermometer to the surface of the body, the temperature does not reflect the real core body temperature and preliminary data, taking by our group, suggest a significant, but stable difference between core body temperatures measured with an indigestible device, compared to the temperature taken with the rectal probe. WBH treatments, currently studied by our group at the University of Arizona, are of mild nature and the constant infra-red heating is stopped, as soon as a patient reaches the rectal temperature of 38.5 C. Due to the fact, that the bodies surface is heated up through the infrared exposure, the investigators assume, that the core body temperature will be lower, compared to the rectal temperature. A validation study in 20 subjects therefore is necessary to determine the differences in the measuring methods. This is especially important, as the end-point of the treatments is defined by the core body temperature, and different endpoints by switching from one measuring method to the other, without validation, would potentially bias the study results.
Receiving a treatment in the WBH machine is of non-significant risk and can be compared to e.g. a sauna visit or an intense exercise, in terms of the physiological reaction. It is currently studied by our group for the treatment of Major Depressive Disorder, PTSD and other chronic illnesses. This trial however will not be limited to only include individuals with MDD or PTSD, but will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). The investigators will monitor subject's physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This study will include safety assessments several days prior to or same day as the WBH, and include follow-up assessments 1 day and 1 week later.
- Conditions
- Core Body Temperature
- Being tested
- ELITE 3 HQ
- Keywords
- core body temperature, whole-body hyperthermia, rectal body temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELITE 3 HQDevice
Also called Core body temperature indigestible measuring device
The pill is about the size of a multivitamin, is coated with special medical plastic, and is easy to swallow. The pill sends radio signals to a small recording device that participants wear that send a signal to a monitor and records the participant's internal body temperature. The pill will exit the participant's body in one of his/her bowel movements approximately 1-5 days after ingestion. Pills are not reused.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in core body temperature
Core body temperature differences as measured by 1) a rectal temperature probe and 2) an approved wireless and indigestible thermometer during a WBH session.
Measured: WBH Heating Session (this takes place at the hospital and lasts approximately 2.5 hours)
Secondary outcomes (3)
Change in Score on the Q-LESQ-SF (Quality of Life Enjoyment and Satisfaction Questionnaire -Short form)
Percent change in scores between baseline and subsequent assessments will be assessed to determine the effect of WBH on self-reported quality of life.
Measured: WBH treatment day and 1 day following WBH treatment
Change in Score on the Positive and Negative Association Scale (PANAS)
Percent change in scores on the PANAS Scale to assess the transient and fluctuating active mood states during the WBH procedure.
Measured: During the WBH Session
Change in Score on Cognition Tests
Measured: WBH treatment day and 1 day following WBH treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: investigator transferred institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core Body TemperatureStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles (Chuck) Raison, University of Arizona
- Investigators
- Charles Raison, MD, Principal investigator, University of Arizona, Department of Psychiatry, College of MedicineClemens Janssen, MS, Study director, University of Arizona, Department of Psychiatry, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340377
- Sponsor's protocol ID
- 14-11566-046
- Status last verified
- Aug 2015
- First submitted
- 13 Jan 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Body Temperature During Hyperthermia in a Whole Body Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology
- ClinicalTrials.gov ID
- NCT02340377
- Acronym / sponsor ID
- 14-11566-046
- Conditions
- Core Body Temperature
- Keywords
- core body temperature, whole-body hyperthermia, rectal body temperature
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: investigator transferred institutions
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Jan 2015 (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 primary objective of the proposed study is to determine the use of a wireless method to monitor and record core body temperature during a Whole Body Hyperthermia treatment, compared to an indwelling rectal thermometer.
This protocol is intended to study the differences between a rectal temperature probe and an approved wireless and indigestible thermometer during a WBH session. The current standard in monitoring core body temperature is the usage of an indwelling rectal thermometer. Many patients and potential study subjects, however, decline receiving the treatment, due to the discomfort of using this measuring method and a wireless measuring device would open the possibility for those patients to receive a treatment. The primary endpoint for example of a treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C. However, due to the proximity of the probe to the body's surface, the core body temperature will vary from the rectal temperature and the comparison between the two methods with a validation of the wireless device is necessary.
The investigators will monitor subject's physiological outcome from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This study will include safety assessments 7 days several days prior to or same day as the WBH, and include follow-up assessments 1 day and 1 week later.
Detailed description
This protocol will allow for the evaluation of a wireless measuring device for core body temperature and a comparison to the data taken with a rectal thermometer, during a Whole Body Hyperthermia (WBH) in various subject populations. The primary objective of the proposed study is a potential change from wired core body temperature measurement with a rectal thermometer to an indigestible thermometer with wireless technology.
The recent standard for measuring core body temperature during WBH procedures is the use of an indwelling rectal thermometer to constantly monitor the temperature for safety and for research reasons. Experiences from different clinics and research groups, including ours, show a high drop-out rate of potential study participants and patients, because of the discomfort of self-inserting a rectal thermometer for the treatment in a Whole-Body Hyperthermia. A wireless and reliable measuring technology would open this treatment for participants, who are declining their participation due to the indwelling thermometer. This device will exit the subject's body via bowel movement 1-5 days following ingestion and will not be reused.
Due to the proximity of the indwelling thermometer to the surface of the body, the temperature does not reflect the real core body temperature and preliminary data, taking by our group, suggest a significant, but stable difference between core body temperatures measured with an indigestible device, compared to the temperature taken with the rectal probe. WBH treatments, currently studied by our group at the University of Arizona, are of mild nature and the constant infra-red heating is stopped, as soon as a patient reaches the rectal temperature of 38.5 C. Due to the fact, that the bodies surface is heated up through the infrared exposure, the investigators assume, that the core body temperature will be lower, compared to the rectal temperature. A validation study in 20 subjects therefore is necessary to determine the differences in the measuring methods. This is especially important, as the end-point of the treatments is defined by the core body temperature, and different endpoints by switching from one measuring method to the other, without validation, would potentially bias the study results.
Receiving a treatment in the WBH machine is of non-significant risk and can be compared to e.g. a sauna visit or an intense exercise, in terms of the physiological reaction. It is currently studied by our group for the treatment of Major Depressive Disorder, PTSD and other chronic illnesses. This trial however will not be limited to only include individuals with MDD or PTSD, but will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). The investigators will monitor subject's physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This study will include safety assessments several days prior to or same day as the WBH, and include follow-up assessments 1 day and 1 week later.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For the purposes of this study we will enroll subjects 18-50 years of age to undergo a Hyperthermia session in an open fashion. We expect approximately 20 - 30 subjects to undergo this open hyperthermia treatment. Subjects must be medically healthy enough to be able to undergo the Hyperthermia session, all exclusion criteria listed below address what is deemed "medically healthy", per self-report by potential subjects. There will be no inclusion of children, pregnant women, mentally impaired individuals, or prisoners in this study.
Key inclusion criteria (4 listed)
- Male or females aged 18-50 years.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Able to communicate in English with study personnel.
- For women of child-bearing potential (i.e., one who is biologically capable of become pregnant,) must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial per self-report.
Key exclusion criteria (29 listed)
- Any of the following diagnoses, as identified by the psychiatric evaluation or study assessments:
- A current DSM-IV-TR Axis I diagnosis of Dementia; or
- Any current DSM-IV-TR Axis II diagnosis (i.e. personality disorder) that would suggest potential noncompliance with the protocol; or
- A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Type 1; or
- A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
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 |
|---|---|---|
| ELITE 3 HQAlso: Core body temperature indigestible measuring deviceThe pill is about the size of a multivitamin, is coated with special medical plastic, and is easy to swallow. The pill sends radio signals to a small recording device that participants wear that send a signal to a monitor and records the participant's internal body temperature. The pill will exit the participant's body in one of his/her bowel movements approximately 1-5 days after ingestion. Pills are not reused. | Device | – |
Primary outcome
Difference in core body temperature
Time frame: WBH Heating Session (this takes place at the hospital and lasts approximately 2.5 hours)
Core body temperature differences as measured by 1) a rectal temperature probe and 2) an approved wireless and indigestible thermometer during a WBH session.
3 secondary outcomes
Change in Score on the Q-LESQ-SF (Quality of Life Enjoyment and Satisfaction Questionnaire -Short form)
Time frame: WBH treatment day and 1 day following WBH treatment
Change in Score on the Positive and Negative Association Scale (PANAS)
Time frame: During the WBH Session
Change in Score on Cognition Tests
Time frame: WBH treatment day and 1 day following WBH treatment
Results and safety
The study was stopped early (reason given: investigator transferred institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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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.
Charles Raison, MD principal investigator
University of Arizona, Department of Psychiatry, College of Medicine
Clemens Janssen, MS study director
University of Arizona, Department of Psychiatry, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Core Body Temperature, run by University of Arizona at 1 site in United States.
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 29 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: stopped early, as of the sponsor's last update on 10 Aug 2015. 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 States. 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 was stopped early (reason given: investigator transferred institutions). Results are not available in the source record.
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?
Difference in core body temperature (time frame: WBH Heating Session (this takes place at the hospital and lasts approximately 2.5 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 10 Aug 2015.