Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R00AT004711-04 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation-First Arm | Experimental | 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. |
|
| Sauna-First Arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sauna Detoxification Protocol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Safety | To evaluate the safety of sauna detoxification by recording and describing all adverse events (AE's) throughout the study. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Allen, ND, MPH | Bastyr University Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bastyr University Research Institute, Clinical Research Center | Kenmore | Washington | 98028 | United States |
Not provided
| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Observation Sessions | Other | 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. |
|
| 6 weeks |
| D014947 | Wounds and Injuries |