Sauna Detoxification Study: Pilot Feasibility
Condition: Hyperthermia
MeSH terms: Hyperthermia
Study type: Interventional
Phase: Phase 1

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).
    

Detailed description: 
      According to our nationwide survey of Naturopathic Physicians regarding use of
      detoxification, approximately 80 percent of NDs (Naturopathic Doctors) use some type of
      detoxification interventions in clinical practice on a regular basis. Of the interventions
      used, 66% of respondents reported using sauna therapy. Of the conditions treated, over 80
      percent of practitioners use sauna-based detoxification for "general cleansing/preventive
      medicine." This protocol will utilize a sauna as the primary method of detoxification.

      Previous studies on hyperthermia-based protocols for detoxification have been
      methodologically challenged and are not readily reproducible. Furthermore, there are no
      studies in the literature that identify how long of a protocol is tolerated, is feasible in
      the general population, or how long is needed to observe PCB (or other pollutant reduction).
      Therefore, we will employ a "high-dose" protocol and a "low-dose" protocol, based on ranges
      reported in the literature, in order to evaluate dose-finding outcomes to hyperthermia,
      including tolerability, retention, and participant-reported outcomes.

      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). Participants will be able to schedule visits
      on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility
      in which days are attended will be utilized to increase likelihood of retention. A
      participant may attend visits for 15 consecutive days, should they wish.

      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). Participants will be able to schedule visits on
      any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in
      which days are attended will be utilized to increase likelihood of retention. Participants
      will be able to attend 9 consecutive sessions, should they wish.
    

Intervention name(s): This protocol will utilize a sauna as the primary method of detoxification.
Intervention type(s): Other
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Detoxification; Sauna