Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-27 @ 11:31 AM
Study NCT ID:
NCT02174003
Status:
TERMINATED
Last Update Posted:
2025-07-31
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Hyperthermia Registry Study
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator transferred to the University of Wisconsin - Madison
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
The WBH procedure proposed in this protocol has been rigorously researched in subjects with Major Depressive Disorder (MDD), and there are little to no preliminary data pertaining to WBH use in populations outside of depression studies. In preliminary studies in Europe and a rigorously tested clinical trial being conducted at the University of Arizona (NCT01625546), a single exposure to WBH resulted in a decrease in depressive symptoms as measured using the German version of the CES-D depression scale 5 days later (in the study in Switzerland) and using the HamD rating scale 7 days later in the UA study. All research applications thus far have resulted in minimal adverse effects to study subjects.
During the conduct of research protocol 12-0147-04/NCT01625546 (WBH in subjects with Major Depression) our research site has been contacted by numerous individuals across the country asking if they can participate in our clinical trial. However due to the rigorous inclusion/exclusion criteria necessary for data collection, these individuals cannot be offered the research treatment. This protocol is intended to become a secondary resort for these individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from other comorbidities (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). In fact, over the course of this study, several individuals who suffer from fibromyalgia, rheumatoid arthritis and other similar afflictions have, in discussions with study staff at screening, indicated that they have previously researched infrared heating and whole body hyperthermia and found that it was helpful to many people with these afflictions. As such, they are interested in being a part of the study in order to receive treatment that might help ease their pain from these afflictions in addition to the depression symptoms they are experiencing, given that depression is often a co-morbidity of these illnesses. Due to the fact that no external research funding has been acquired for this broad application, this protocol intended to charge a fee for cost covering purposes only.
The registry trial will not be limited to only include individuals with MDD, 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.
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.
During the conduct of research protocol 12-0147-04/NCT01625546 (WBH in subjects with Major Depression) our research site has been contacted by numerous individuals across the country asking if they can participate in our clinical trial. However due to the rigorous inclusion/exclusion criteria necessary for data collection, these individuals cannot be offered the research treatment. This protocol is intended to become a secondary resort for these individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from other comorbidities (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). In fact, over the course of this study, several individuals who suffer from fibromyalgia, rheumatoid arthritis and other similar afflictions have, in discussions with study staff at screening, indicated that they have previously researched infrared heating and whole body hyperthermia and found that it was helpful to many people with these afflictions. As such, they are interested in being a part of the study in order to receive treatment that might help ease their pain from these afflictions in addition to the depression symptoms they are experiencing, given that depression is often a co-morbidity of these illnesses. Due to the fact that no external research funding has been acquired for this broad application, this protocol intended to charge a fee for cost covering purposes only.
The registry trial will not be limited to only include individuals with MDD, 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: