Recruiting

Cold & Heat

Sponsor:

Barry Sandler

Code:

NCT06263738

Conditions

Depression

Mood Disorders

Healthy (Controls)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Whole Body Hyperthermia

Cold Water Plunge

Study Details

Brief summary:

This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.

Conditions

Depression

Mood Disorders

Healthy (Controls)

Study ID

NCT06263738

Start date

May 14, 2024

Status verified date

Nov, 2025

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals who currently meet study criteria for depression or individuals who do not currently meet criteria for depression
  • English or Spanish speaking (able to provide informed consent and complete questionnaires in one of these languages)
  • Able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations.

Exclusion Criteria:

  • Previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure
  • Use of any medication that may impact thermoregulatory capacity.
  • Pregnancy, active lactation, or intention to become pregnant during the study period.
  • Endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months.

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Depression + Whole Body Hyperthermia

Participants experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes.

active comparator: Depression + Whole Body Hyperthermia + Cold Water Plunge

Participants experiencing depression will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes.

active comparator: No Depression + Whole Body Hyperthermia

Participants not experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes.

active comparator: No Depression + Whole Body Hyperthermia + Cold Water Plunge

Participants not experiencing depression will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes.

Interventions

Whole Body Hyperthermia

Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes

Cold Water Plunge

Participants in the heat exposure and cold plunge group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session in 55 degree (Fahrenheit) water, lasting up to 10 minutes.

Primary outcome measure

  • Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3) ]

Central Contacts and Locations

Central contacts

Study Coordinator

970-855-7374BHIC@vailhealth.org

Locations

Vail Health Behavioral Health Innovation Center

Recruiting

Edwards, Colorado, United States, 81632

Contacts

Study Coordinator

970-445-2489BHIC@vailhealth.org

Principal Investigator:

Barry Sandler, DO

More Information

Sponsor

Barry Sandler

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • Depression
  • Mood Disorders
  • Mental Health
  • Integrative Health
  • Hyperthermia
  • Sauna
  • Cold Plunge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barry Sandler on 2025-11-13.