A Phase 1 interventional study of Sauna Detoxification Protocol and Observation Sessions in Hyperthermia, sponsored by Bastyr University. Terminated at 1 site in United States. Open to participants aged 21 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-17.
Sponsored by Bastyr University · Phase 1 and Interventional
The purpose of this study is to determine the impact of sauna use on polychlorinated biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety, feasibility, and tolerability, and effects on quality of life and wellness. We hope to determine if there is a link between lower PCB levels in blood and sauna use.
This is a Phase I, 2-Arm randomized trial.
All study participants will actively undergo sauna intervention sessions and observation sessions.
The time between Phone Screen and the End of Study Visit will vary by individual schedule. For the purposes of this study, a participant will be considered 'actively enrolled' when s/he has signed the Full Study Consent Form on the first sauna or observation visit (SV1 or OV1). Each participant will be actively enrolled for at least 7 weeks, but no more than 22 weeks.
All participants will undergo Phone Screen for eligibility prior to participating in any study-related visits. Candidates will first be asked for their oral consent to be screened, and if granted, questioning will continue. If the participant meets pre-screening criteria assessed on the phone, they will be asked to schedule an In-Person Screening Visit.
Prior to randomization, all participants will participate in an In-Person Screening Visit at the Bastyr University (BU) Clinical Research Center (CRC) for: informed consent, to have a blood draw for screening lab analysis, anthropomorphic measurements, a 12-lead ECG assessment, provide demographic data, and medical history assessment.
If participants remain interested and eligible, they will be randomized into either Sauna-First Arm or Observation-First Arm within 2 weeks of eligibility ascertainment using block randomization scheme.
Participants will know that they are in an intervention, but will not know their PCB levels, or the results of questionnaire assessments until approximately three months after the end of the study. The PI will review monitoring and AE data, but will be blinded to PCB data during analysis.
After screening, randomization, and informed consent, study participants in either Arm will either complete a 3-week observation period followed by a 3-week medically monitored sauna-based detoxification intervention; or will first complete a 3-week medically monitored sauna-based detoxification intervention, followed by a 3-week observation period. Each participant will also have an End of Study Visit at least 7 days after the last study visit (Sauna or Observation Visit -depending on the Arm).
The sauna will be pre-warmed to 160 degrees Fahrenheit and humidity set to 25% +/- 5%. Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time vital signs, symptoms, and fluid intake will be assessed and recorded.
During Sauna Visits weekly lab assessments will be performed to compare participants' baseline lab values with those during the sauna intervention, and to monitor for safety. In addition, weekly serum samples will be taken for PCB assessment.
During each Observation Visit a blood draw for Complete Blood Count with Differential (CBC/D), Comprehensive Metabolic Panel (CMP), and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed.
481 studies on the registry are indexed under Hyperthermia; 92 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 368 interventional studies indexed under Hyperthermia.
Browse Hyperthermia studies →Bastyr University is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
A group that first attends 4 observation visits without sauna, and then attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks. Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols.
Other: Sauna Detoxification Protocol · Other: Observation Sessions
A group that first attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks and then attends 4 observation visits without sauna. Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols.
Other: Sauna Detoxification Protocol · Other: Observation Sessions
All study participants will actively undergo sauna intervention sessions. The sauna will be pre-warmed to 160 degrees Fahrenheit and humidity set to 25% +/- 5%. Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time vital signs, symptoms, and fluid intake will be assessed and recorded. On a weekly basis, lab assessments will be performed to compare participants' baseline lab values with those during the sauna intervention, and to monitor for safety. In addition, weekly serum samples will be taken for PCB assessment.
Also known as: Sauna-based detoxification
All enrolled participants will undergo observation protocol consisting of one (1) hour visit weekly consistent with Sauna Visits lab assessment time points, to be completed in 3 weeks (4 total sessions within 21 days). At each Observation Visit a blood draw for CBC/D, CMP, and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed.
Impact of sauna protocol on PCB levels
The primary comparison measure will be PCB levels at Sauna Visit 15 in the sauna-first Arm and Observation Visit 4 in the Observation-First Arm.
Time frame: 6 weeks
Safety
To evaluate the safety of sauna detoxification by recording and describing all adverse events (AE's) throughout the study.
Time frame: 6 weeks
Participant-Reported Symptoms
To describe changes in quality of life and participant-reported symptoms associated with participation in the study. Query for symptoms will be recorded daily during all sauna visits (SV1-15), at each observation visit (OV1-4), and at the End of Study Visit. The RAND Short Form 36 Questionnaire, and NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaires: Global Wellness, Fatigue, Physical Function will be assessed at SV1, OV1, and End of Study Visit.
Time frame: 6 weeks
The record gives a start of Jul 2013, a primary completion of Sep 2013 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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