This study is no longer open to enrollment. Please check back in the Fall for a new study involving alternative treatment for depression.
The primary objective of the proposed study is to determine if Whole Body Hyperthermia (WBH) can have beneficial effects in various subject populations currently experiencing numerous other comorbidities, and the duration of the effect(s).
We are conducting this open registry study because during our main study ‘Whole Body Hyperthermia for Major Depressive Disorder” (see mddstudy.org), we have been repeatedly contacted by people across the country hoping to participate, but who are unable because of our rigorous inclusion/exclusion criteria. Therefore, we have designed this study as a secondary resort for those individual’s interested in receiving a whole body hyperthermia treatment for potential beneficial gain related to symptoms stemming from other illnesses such as Fibromyalgia, Perimenopausal symptoms, arthritis, depression, chronic fatigue syndrome etc.
Because this is a registry study and there is no external research funding for its conduct, we must charge a fee to those who wish to participate. The fee is intended to cover the costs of conducting the safety labs and whole body hyperthermia session and is no way generating a profit for the research team.
You may be eligible if you meet the following entry requirements:
- 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 cannot participate if you:
Have a medical condition or disorder that:
- Is unstable and clinically significant, or:
- Could 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,
5) individuals with a fever the day of study intervention (if so, they will be rescheduled),
6) individuals with hypersensitivity to heat,
8) 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.
Study Screening
Our screening involves a two-step process. The first step is via phone, the second step is an in-clinic visit.
Phone Screening:
Phone screening with a member of our staff (takes between 10 and 30 minutes to complete). You will be asked questions about your depression and your medical and health history.
In-Clinic Screening:
If you pass the phone screening, we will schedule an in-clinic screening visit which will take about 1 hour. During this visit you will:
- Complete several questionnaires
- Have a blood draw and electrocardiogram to make sure you are medically health
- Have a routine urine test to ensure that you are not pregnant (for women) and/or are not taking any recreational drugs that could interfere with the results of the study.
- If you screen eligible, five days following your in-clinic screening, we will send you an on-line questionnaire to fill out.
Based on the results of your questionnaire responses and lab tests, we will determine if you are eligible to participate in the study. If you are eligible, we will provide you with a sleep diary and ask you to track your sleep patterns. You will track your sleep patterns for one week before and one week after your WBH treatment session.
NOTE: If you do not live in Tucson, AZ, please contact our research staff to discuss how these procedures can be done remotely.
Study Visits
Visit 1- WBH Treatment Day:
If you qualify for the study, we will schedule you for your WBH Treatment Day. This will require you to be in the clinic for a half day visit.
During this visit you will fill out some questionnaires and have a few non-invasive assessments. The heating session will begin at 1pm and will last 2 hours and 20 minutes.
During the heating session, you will be lying on a standard hospital stretcher, enclosed by a heating tent (see picture above).
- Different people respond differently to the infrared treatment, but your body temperature may rise as high as 38.5 C (101.3 F).
- Your vital signs will be continuously monitored, and the infrared session will be recorded both for safety and for investigators to examine your behavior during the infrared session.
- You will be asked to answer some questions during the session.
- Following the session you will again fill out some questionnaires.
A participant lies in the WBH device.
Visit 2 – 1 Week Follow-Up (Online):
- You will be sent a confidential link to fill out the same questionnaires that you filled out at screening and on the WBH Treatment Day.
Costs for Participating in the Study
The WBH session is an investigational procedure, one approved for limited testing by the Food and Drug Administration (FDA) but not in general use. In addition to your time, you will be charged a fee of $800 for cost covering purposes only. The cost for this open treatment hyperthermia session will cover departmental staff time, clinical space, research materials, and overhead fees. You may pay with cash, check, or credit card. If you wish to pay with a credit card, a 3% fee will be assessed to cover credit card processing fees. All payments will be made to the Department of Psychiatry and will be processed by our Departmental business office.
The payment may be broken into 2 tiers:
- Screening $200
- WBH Procedure $600
If you qualify for WBH procedure the remaining $600 will be due prior to completion of the procedure.
If you pay in full and it is determined you do not qualify for the study, you will be reimbursed less any amount needed to cover procedures performed (i.e. screening).
Future WBH Treatment Sessions:
If you wish to undergo another WBH procedure, you may do so without have to repeat screening bloods and EKG’s within 1 year of the original screen, so long as you report no significant changes in your health history to the study staff. You will not be charged for screening procedures for subsequent WBH procedures. Those individuals who have participated in previous WBH protocols will be considered eligible without need for a re-screen within 1 year of their original screening procedures.