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Whole Body Hyperthermia Registry Study

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ClinicalTrials.gov Identifier: NCT02174003
Recruitment Status : Terminated (Investigator transferred to the University of Wisconsin - Madison)
First Posted : June 25, 2014
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Charles (Chuck) Raison, University of Arizona

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.


Condition or disease Intervention/treatment
Depression Anxiety PTSD Fibromyalgia Chronic Fatigue Syndrome Device: High intensity whole-body infrared heating

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2 participants
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Study Start Date : June 2014
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
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
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.
Other Name: WBH




Primary Outcome Measures :
  1. Change in depression scores over time [Inventory of Depressive Symptomatology—Self Report (IDS-SR)] [ Time Frame: Screening, WBH treatment day and 1 week following treatment. ]
    Percent change in scores between baseline and subsequent assessments will be assessed


Secondary Outcome Measures :
  1. Change in Positive and Negative Affect [ Time Frame: Screening, WBH treatment and 1 week following WBH treatment ]
    Percent change in positive and negative affect will be assessed between baseline and subsequent assessments using the Positive and Negative Affect Schedule (PANAS)

  2. Change in Morning / Evening Questionnaire [ Time Frame: Screening, WBH Treatment day, 1 week following WBH Treatment ]
    Percent change in morning versus evening behavioral preferences will be assessed between baseline and subsequent assessments using the Morningness and Eveningness Questionnaire (MEQ).

  3. Change in Quality of Life [ Time Frame: Screening, WBH Treatment Day and 1 week following WBH treatment ]
    Percent change in scores using the Quality of Life Enjoyment and Satisfaction (Q-LESQ-SF) questionnaire.

  4. Change in functional impairment [ Time Frame: Screening, WBH Treatment Day and 1 week following WBH treatment day ]
    Percent change in score on the Sheehan Disability Scale to assess improvements in work/school, social and family life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174003


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Charles Raison, MD University of Arizona, Department of Psychiatry, College of Medicine

Additional Information:

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Responsible Party: Charles (Chuck) Raison, Associate Professor, Department of Psychiatry (College of Medicine) and the Norton School of Family and Consumer Sciences, University of Arizona
ClinicalTrials.gov Identifier: NCT02174003     History of Changes
Other Study ID Numbers: 1406365027
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Charles (Chuck) Raison, University of Arizona:
whole body hyperthermia
depression
fibromyalgia
rheumatoid arthritis
perimenopausal symptoms
open treatment
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Myofascial Pain Syndromes
Fatigue
Fibromyalgia
Depression
Behavioral Symptoms
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Encephalomyelitis
Central Nervous System Diseases