Sauna Detoxification Study: Pilot Feasibility

Completed · Phase 1

Conditions studied: Hyperthermia

In brief

The goal of this study is to assess the feasibility of the approach, conduct a dose-finding investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials in the assessment of human chemical body burden reduction, for general wellness, detoxification, and pain reduction. The investigators wish to determine if a hyperthermia-based detoxification protocol is feasible to conduct: including assessment of recruitment, enrollment, retention, protocol adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).

Key facts

Study ID

NCT01576822

Run by

Bastyr University

People needed

10

Starts

2011-11-01

Expected to finish

2012-04-01

Last updated by the study team

2012-10-30

Who can join

Age: 21 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 21-35 years.
• Body mass index (BMI) 19 to 30 kg/m2 at the screening evaluation.
• Ability to schedule and attend daily visits for the duration of the study.
• If female, willingness to use barrier contraception (e.g., cervical cap, diaphragm, condom, metal IUD (non- hormone)) throughout the study and take a pregnancy test at screening, and weekly during the study.

You may not qualify if…

• Pregnant, or trying to become pregnant in the three months following screening.
• Current use of any prescribed pharmaceutical medications (including oral contraceptive pills, without additional barrier contraception).
• Participants who have a BMI greater than 30 kg/m2, elevated fasting blood sugar, bradycardia, hyper or hypotension or evidence of a medical condition.
• A diagnosis of any chronic medical condition (e.g., multiple sclerosis, diabetes, or endocrine disorders, liver disease, kidney disease, HIV/AIDS, or cancer, or with a reported history of substance abuse or mental illness within the past 5 years, or a mental health disorder in the past 6 months.
• Clinical chemistry lab values outside of reference lab normal ranges (except in cases of ranges within 10% ULN and isolated measurements in the absence of chronic disease).
• Recent infection (<14 days), open sores, or communicable skin conditions.
• Current use of any tobacco products or illicit drugs.
• Any condition that in the opinion of the investigators or IRB would preclude the safe completion of the study (e.g., clinical or mental health concerns that arise from the screening questionnaire or physical exam).

Where it is running

• Bastyr University Clinical Research Center — Kenmore, Washington, United States

Full record on ClinicalTrials.gov

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