Core Body Temperature Clinical Trial
Official title:
Core Body Temperature During Hyperthermia in a Whole Body Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology
| Verified date | August 2015 |
| Source | University of Arizona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 30 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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: 1. individuals who are using prescription drugs that may impair thermoregulatory cooling, 2. individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease) 3. 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, 4. individuals with a fever the day of study intervention (if so, they will be rescheduled), 5. individuals with hypersensitivity to heat, 6. 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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Arizona | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| University of Arizona |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | WBH Heating Session (this takes place at the hospital and lasts approximately 2.5 hours) | No |
| Secondary | 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. | WBH treatment day and 1 day following WBH treatment | No |
| Secondary | 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. | During the WBH Session | No |
| Secondary | Change in Score on Cognition Tests | WBH treatment day and 1 day following WBH treatment | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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