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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00AT004711-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Active Comparator | 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. |
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| High Dose | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This protocol will utilize a sauna as the primary method of detoxification. | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment/Retention | Assess recruitment/retention goals/milestones | Up to 6 months |
| Protocol adherence | Assess protocol adherence | Up to 6 months |
| Change from baseline in Clinical Chemistry Panel | Complete metabolic panel, within normal limit (y/n)? | Baseline and 4 weeks |
| AE Monitoring | Adverse event monitoring tool: FDA Monitoring of Side Effects System (MOSES) | Up to 6 months |
| Vital signs | Vital signs within normal limits (y/n)? | Up to 6 months |
| Participant-reported outcome questionnaire | NIH PROMIS Questionnaire | Baseline and up to 4 weeks |
| Short Form 36 health survey | Health survey questionnaire | Basleine and up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Polychlorinated biphenyls | Measure serum concentrations of PCBs | Baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Allen, N.D., MPH | Bastyr University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bastyr University Clinical Research Center | Kenmore | Washington | 98028 | United States |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| D014947 | Wounds and Injuries |