Hyperthermia Safety Study Uses Temperature Management System to Gently Raise Participant's Body Temperature to a Fever-range Level in a Controlled Setting.

Official title

Clinical and Biological Safety Study of the BTT Hyperthermia in Adult Subjects

Overview

The Abreu BTT 700 Temperature Management System (TMS) is a device that gently raises the body temperature of the participant to a fever-range level in a controlled setting. There will be one study treatment session. with the TMS system and four safety assessments: before the session, about two hours afterward, on the next day, and again on the third day after the session. Your participation in the study will last about three days in total. An electrocardiogram (ECG - traces the electrical activity of the heart) will be performed during screening. This is not a randomized or blinded study -- all participants will receive the same study treatment. The TMS system has been previously used in other settings, but this study is designed specifically to collect safety data in adult volunteers.

Detailed description

Participants are being asked to take part because they are healthy adults between the ages of 18 and 65 and have no history of any heart, cancer, or neurological disorders. Participation in this study will help researchers understand how healthy people respond to this technology before it is tested in people with specific medical conditions.

Voluntary Participation: Taking part in this study is completely voluntary. Volunteers do not have to participate and may withdraw at any time. Stopping to participate in the study will not result in any penalties or loss of benefits.

Benefits, Compensation, and Risk: Subjects may not receive any direct benefit from participating in this study. However, participation will help researchers develop safer treatments for others in the future. There is no cost to participate.

Possible risks include feeling tired, sweating, or experiencing temporary changes in heart rate or blood pressure. Rare but serious risks could include overheating, dehydration, or fainting. The study team will monitor you closely throughout the process to minimize risks and will stop the session immediately if there are any safety concerns.

Interventions

• Other Hyperthermia
  controlled induced hyperthermia

Primary outcome measures

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment)]
• Change in Cardiovascular Vital Signs (Heart Rate) [Time frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment)]
• Change in Cardiovascular Vital Signs (Blood Pressure) [Time frame: Baseline (pre-treatment) through post-treatment (48-hours post treatment)]]
• Change in Comprehensive Metabolic Panel Renal Function Markers (Creatinine) [Time frame: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)]
• Change in Comprehensive Metabolic Panel Renal Function (BUN) [Time frame: Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)]
• Change in Comprehensive Metabolic Panel Renal Function (eGFR) [Time frame: Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)]
• Change in Comprehensive Metabolic Panel Hepatic Function (AST) [Time frame: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)]
• Change in Comprehensive Metabolic Panel Hepatic Function (ALT) [Time frame: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)]
• Change in Comprehensive Metabolic Panel Hepatic Function (ALP) [Time frame: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)]
• Change in Comprehensive Metabolic Panel Hepatic Function (Total Bilirubin) [Time frame: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)]

Secondary outcome measures (4)

• Change in Respiratory Parameters (Respiratory Rate) [Time frame: Pretreatment through 48hrs. after the treatment]
• Change in Respiratory Parameters (Oxygen Saturation) [Time frame: Pretreatment through 48hrs. after the treatment]
• Change in Pulmonary Function (FEV1) [Time frame: Pretreatment and 48hrs. after the treatment]
• Change in Pulmonary Function (FVC) [Time frame: Pretreatment and 48hrs. after the treatment]

Eligibility criteria

Inclusion criteria

\- A person who meets all of the following criteria will be eligible for this study:

• Provision of signed and dated informed consent/assent form.

• Ability to understand the nature of the study and protocol requirements and provide written informed consent.
• Willingness to comply with all study procedures and availability for the duration of the study.
• Aged over 18 years and no more than 65 years
• Males and Female
• Values of vital signs before BTT Hyperthermic Induction should be:

• Systolic between 100-140 mm Hg o diastolic between 50-90 mm Hg
• cardiac pulse between 45-90 beats per minute
• Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatory drugs)

Exclusion criteria

• History of Cardiovascular and venous thrombosis disorders

• History of auto-immune disorders
• History of pulmonary disease
• History of Neurological disorders
• History of Cancer disorders
• Renal or Hepatic insufficiency
• Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects who do not support high fever range in the past during adult or childhood life.
• Pathology evolutionary time of the review of inclusion
• Excessive consumption of alcohol, tobacco (over 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse.
• The person(s) with the following condition(s) are excluded to participate in the study

• Implanted electronic devices
• Any metal implant
• Dermatological conditions sensitive to heat
• Any enclosed infection that, as assessed by a qualified physician, serves as a contraindication for hyperthermia
• Clinically significant ECG findings, as per determined by a cardiologist, including uncontrolled arrhythmia
• A subject who in the opinion of the Principal Investigator would not be able to safely complete the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• BTT Medical Institute LLC — Aventura

Publications

• Oehler R, Pusch E, Zellner M, Dungel P, Hergovics N, Homoncik M, Eliasen MM, Brabec M, Roth E. Cell type-specific variations in the induction of hsp70 in human leukocytes by feverlike whole body hyperthermia. Cell Stress Chaperones. 2001 Oct;6(4):306-15. doi: 10.1379/1466-1268(2001)0062.0.co;2. PMID 11795467
• Brazaitis M, Eimantas N, Baranauskiene N, Kilikeviciene S, Vitkauskiene A, Daniuseviciute L. Effects of severe whole-body hyperthermia on ovarian hormone and extracellular Hsp72 responses in young adult women. Int J Hyperthermia. 2019;36(1):660-665. doi: 10.1080/02656736.2019.1627431. PMID 31317816
• Evans SS, Repasky EA, Fisher DT. Fever and the thermal regulation of immunity: the immune system feels the heat. Nat Rev Immunol. 2015 Jun;15(6):335-49. doi: 10.1038/nri3843. Epub 2015 May 15. PMID 25976513
• Zauner D, Quehenberger F, Hermann J, Dejaco C, Stradner MH, Stojakovic T, Angerer H, Rinner B, Graninger WB. Whole body hyperthermia treatment increases interleukin 10 and toll-like receptor 4 expression in patients with ankylosing spondylitis: a pilot study. Int J Hyperthermia. 2014 Sep;30(6):393-401. doi: 10.3109/02656736.2014.956810. PMID 25256892
• Mason AE, Chowdhary A, Hartogensis W, Siwik CJ, Lupesko-Persky O, Pandya LS, Roberts S, Anglo C, Moran PJ, Nelson JC, Lowry CA, Patrick RP, Raison CL, Hecht FM. Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT). Int J Hyperthermia. 2024;41(1):2351459. doi: 10.1080/02656736.2024.2351459. Epub 20 PMID 38743265
• Mason AE, Hartogensis W, Chowdhary A, Siwik CJ, Pandya LS, Jung E, Lupesko-Persky O, Hartley E, Hopkins L, Roberts S, Borovinsky J, Nelson JC, Lowry CA, Patrick RP, Moran PJ, Raison CL, Hecht FM. A Randomized Trial Testing a Novel Mind and Body Intervention for Depression: Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH). Glob Adv Integr Med Health. 2025 Oct 22;14:2753613025138 PMID 41146956
• Hanusch KU, Janssen CW. The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? Int J Hyperthermia. 2019;36(1):573-581. doi: 10.1080/02656736.2019.1612103. PMID 31159624
• https://clinicaltrials.gov/ct2/show/NCT03906149?term=Depression&cond=Hyperthermia&cntry=DE&city=Essen&rank=1 Whole-body Hyperthermia for Moderate to Severe Depressive Disorder (HYPE2)

Identifiers

NCT: NCT07564440 · BTT 25-001 SS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗