MedDataX Logo

Cold and Heat Investigation to Lower Levels of Depression

NCT ID: NCT06263738

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The CHILL'D Study aims to figure out how using heat exposure as a treatment for major depressive disorder (MDD) can work better. The researchers want to see if being exposed to heat followed by cold plunge can help people feel better emotionally compared to just being exposed to heat alone.

To answer study questions, 112 adults, ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria, will be randomized with 1-to-1 allocation to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge.

A second cohort of up to 50 adults, ages 18 to 65 not experiencing MDD will be randomized with 1-to-1 allocation to the same interventions.

Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes. 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 lasting up to 10 minutes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Mood Disorders Healthy (Controls)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression Mood Disorders Mental Health Integrative Health Hyperthermia Sauna Cold Plunge

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Depression + Whole Body Hyperthermia

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

Group Type ACTIVE_COMPARATOR

Whole Body Hyperthermia

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Whole Body Hyperthermia

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Whole Body Hyperthermia

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Whole Body Hyperthermia

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Infrared Sauna Whole Body Heating Cold Plunge Cold Water Exposure

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Steadman Philippon Research Institute

OTHER

Sponsor Role collaborator

Barry Sandler

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barry Sandler

Medical Director of Vail Healthspan

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barry Sandler, DO

Role: PRINCIPAL_INVESTIGATOR

Vail Health Behavioral Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vail Health Behavioral Health Innovation Center

Edwards, Colorado, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Coordinator

Role: CONTACT

Phone: 970-855-7374

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20244106

Identifier Type: -

Identifier Source: org_study_id