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
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|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||2 participants|
|Target Follow-Up Duration:||1 Week|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||August 2016|
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
- 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
- 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)
- 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).
- 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.
- 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.
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
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Charles Raison, MD||University of Arizona, Department of Psychiatry, College of Medicine|