Whole Body Hyperthermia Registry Study

NCT02174003 | Terminated

• 1 other identifier: 1406365027
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Anxiety; PTSD; Fibromyalgia; Chronic Fatigue Syndrome

Keywords

whole body hyperthermia; depression; fibromyalgia; rheumatoid arthritis; perimenopausal symptoms; open treatment

Outcome Measures

Primary Outcomes (1)

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

  Percent change in scores between baseline and subsequent assessments will be assessed

  Screening, WBH treatment day and 1 week following treatment.

Secondary Outcomes (4)

• Change in Positive and Negative Affect

  Screening, WBH treatment and 1 week following WBH treatment

• Change in Morning / Evening Questionnaire

  Screening, WBH Treatment day, 1 week following WBH Treatment

• Change in Quality of Life

  Screening, WBH Treatment Day and 1 week following WBH treatment

• Change in functional impairment

  Screening, WBH Treatment Day and 1 week following WBH treatment day

Study Arms (1)

Open Treatment Group

The Open Treatment Group (all participants in this study) will receive the active / WBH treatment in an open fashion.

Device: High intensity whole-body infrared heating

Interventions

High intensity whole-body infrared heating DEVICE

The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.

Also known as: WBH

Open Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the purposes of this study we will enroll subjects 18 years and older to undergo a Hyperthermia session in an open fashion. We expect approximately 20-30 subjects per year 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". Inclusion into this study will require that the minimum safety standards described in the eligibility criteria, there will be no inclusion of children, pregnant women, mentally impaired individuals, or prisoners in this registry. Subjects who appear to have Major Depressive Disorder will be referred to Protocol 12-0147-01 due to the specific aims pertaining directly to depressive symptoms.

You may qualify if:

• 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.

You may not qualify if:

• 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 peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
• History of stroke, epilepsy or cerebral aneurisms
• Diabetes mellitus types I or II.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Fibromyalgia; Fatigue Syndrome, Chronic; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Charles Raison, MD

  University of Arizona, Department of Psychiatry, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 25, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 31, 2025

Record last verified: 2015-07

Locations

US (1)