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Sauna Detoxification Study: Pilot Feasibility

NCT01576822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-10-30

No results posted yet for this study

Summary

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).

Conditions

  • Hyperthermia

Interventions

OTHER

This protocol will utilize a sauna as the primary method of detoxification.

This study is a randomized, 2-arm, dose-finding safety and feasibility trial. After screening, informed consent and randomization, participants will complete a medically-monitored sauna-based detoxification program. High Dose Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna). Low Dose Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna).

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Bastyr University

    lead OTHER

Principal Investigators

  • Jason Allen, N.D., MPH · Bastyr University

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576822 on ClinicalTrials.gov