TerminatedNot Applicable

Whole Body Hyperthermia Registry Study

Stopped: Investigator transferred to the University of Wisconsin - Madison

United States2 participantsStarted 2014-06

Plain-language summary

This protocol will allow for the implementation of a research registry pertaining to Whole Body Hyperthermia (WBH) use in various subject populations. The primary objective of the proposed study is to determine if WBH can have beneficial effects in various subject populations currently experiencing numerous other comorbidities, and the duration of the effect(s). This protocol is intended to become a secondary resort for individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from comorbidities other than depression (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). Due to the fact that no external research funding has been acquired for this broad application this protocol is intended to charge a fee for cost covering purposes only. The registry trial will not be limited to only include individuals with major depressive disorder, however, this protocol will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). We 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 registry study will include safety assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female outpatients aged 18+. * 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 or Spanish with study personnel. Exclusion Criteria: * 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, * Women who are pregnant 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 pe…

What they're measuring

Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]

Timeframe: Screening, WBH treatment day and 1 week following treatment.

Trial details

NCT IDNCT02174003

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-08