MenopauseNCT06192329
Hot Water Therapy for the Treatment of Menopause-related Hot Flashes
A study testing Hot water therapy and Warm water immersion in people with Menopause and Menopause Related Conditions, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial summary
The purpose of this research is to determine whether hot water therapy (i.e. taking prolonged hot baths on multiple consecutive days) decreases hot flash symptoms and improves mood in women who are undergoing or who have underwent menopause. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Menopause Related Conditions, Menopause Syndrome
- What is being tested?
- Hot water therapy and Warm water immersion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported menopause-related hot flashes
Who cannot join
- Diagnosed with a cardiovascular illness that precludes them from taking part in exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Hybl Sports Medicine and Performance Center
Colorado Springs, Colorado, 80918
About this study
Official title: Hot Water Therapy for the Treatment of Menopause-related Hot Flashes and Other Symptoms: a Clinical Trial
The purpose of this research is to determine whether hot water therapy (i.e. taking prolonged hot baths on multiple consecutive days) decreases hot flash symptoms and improves mood in women who are undergoing or who have underwent menopause. It is hypothesized that women who undergo hot water therapy will have reduced hot flash symptoms and improved mood.
Initial tracking period: Women who volunteer to participate in this study will be asked to track the frequency and intensity of their hot flash and other menopause-related symptoms for an initial two week period. Afterwards, they will start their heat therapy program.
Read more
Physiological assessments: On days 1, 7, and 13 of the heat therapy sessions, the participants will enter a climate controlled room to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min, after which the humidity in the climate chamber will be progressively increased until their core temperature begins to increase (~2 hour total time). Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (~1 tsp) blood sample will be taken, to assess how the participants respond to the heat stress. These sessions should take less than 3 hours to complete.
Hot water therapy sessions: Upon enrolling in the study, the participants will be assigned to one of two groups: water bathing at 105°F or 97°F in the lab. On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves to a water level at the shoulders for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min).
Post-intervention tracking period: after completing the heat therapy sessions, the participants will be asked to continue to take baths at home once every 4 days for 1 month. During this time, the participants will be asked to record the intensity and frequency of their hot flashes daily and other menopause-related symptoms weekly. At the end of this month the participants will be given a final exit survey, in order for them to provide the researchers information about their experience participating in the study.
Read the detailed description
Menopause is the time at which menstruation stops and perimenopause is the period before, characterized by a continuous reduction in estrogen and progesterone levels in the blood. Concurrently, the reductions in estrogen leads to a rise in another hormone, orexin. The reduction in circulating estrogen and progesterone and the increase in circulating orexin have been demonstrated to play a major role in menopause-related hot flashes and night sweats, known as vasomotor symptoms (VMS), as well as other symptoms such as mood disorders.
While hormonal replacement therapy remains the most effective defense against VMS, there has been a progressive decline in its prescription due to side effects such as uterine bleeding, increased risk of thromboembolism, as well as increased rates of gallbladder, breast, endometrial, and urinary cancers, highlighting the need for alternative non-hormonal treatments.
Exercise, and specifically the thermoregulatory benefits of exercise (i.e. increased sweating and skin blood flow, as well as reduced core temperature), improves vasomotor symptoms in women going through menopause. Heat acclimation/heat therapy improves thermoregulatory responses by more than twice as much as exercise alone, however, to date, no studies have investigated the effects of heat acclimation on menopause-related vasomotor symptomology.
Accordingly, the purpose of this study will be to examine whether hot water bathing improves vasomotor symptomology, with the guiding hypothesis that hot water bathing will reduce vasomotor symptomology.
Recruitment For this study, we will aim to recruit 100 women who have either undergone or who are undergoing menopause and who self-report experiencing vasomotor symptomology.
Study protocol An initial visit will be organized during which the potential participants will complete a health screening and consent to participate in the study. After which, the participants will undergo a two week-long baseline period during which they will track their vasomotor symptomology using a vasomotor symptomology journaling template, as well as complete a standardized menopause symptomology questionnaire. The participants will be randomized into two groups: a hot water bathing group and a sham group.
Following the baseline period, participants will report to the climate chamber located in the Hybl center to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min after which the humidity in the climate chamber will be progressively increased until an inflection in the participants' core temperature is detected. Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (~1 tsp) blood sample will be taken, to assess heat loss adaptations.
Next, the participants will begin their 10-day, hot water bathing sessions. The participants in the treatment group will be asked to submerge themselves in a bathtub filled with 105°F (40.5°C) water, and to remain at this depth until their esophageal temperature reaches 101.5°F (38.6°C). Based on previous hot water therapy studies using this protocol, this should take approximately 25-35 min. After attaining the target core temperature, the participants will be given a stool to sit on in order for them to remain at waist depth in the water in order to maintain their core temperature at 101.5°F (38.6°C) for an additional 60 min. Participants in the sham group will be immersed up to the shoulder in a 97°F (36°C) tub for 30 min and then to waist-level for another 60 min in order to mimic the same hydrostatic pressures as were experienced by the participants in the heat therapy group, but without the heat exposure.
Finally, following the heat therapy sessions, the participants will be asked to take hot baths at home once every four days (as this is the frequency needed to stay heat acclimated) for one month, while continuing to track their vasomotor symptomology. At the completion of this follow up period, they will complete a study exit survey that has questions regarding their experience in the study.
- Conditions
- Menopause, Menopause Related Conditions, Menopause Syndrome
- Being tested
- Hot water therapy, Warm water immersion
- Keywords
- heat therapy, hot water therapy, hot water immersion, vasomotor syndrome, hot flashes, hot flushes
- Medical subject headings
- Hyperthermia, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot water therapyBehavioural
Also called heat therapy, hot water immersion
On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 105°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min).
Warm water immersionBehavioural
Also called Control trial, Sham trial
On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 97°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min).
| Study group | Role | What they receive |
|---|---|---|
| Warm water immersion | Sham comparator | On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 97°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min). Receives: Behavioral: Warm water immersion |
| Hot water immersion | Experimental | On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 105°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min). Receives: Behavioral: Hot water therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greene climacteric questionnaire
This is a standard questionnaire used to quantify the intensity of 21 common menopause-related symptoms. The score for each question ranges in intensity from 0 (not at all) to 3 (extremely).
Measured: One month pre therapy through to one month post therapy
Daily hot flash diary
Based on industry-standard hot flash diaries, this tracks the number and intensity (where 1 is none and 10 is extreme) of hot flashes, night sweats, and mood disruptions that the participants feel.
Measured: One month pre therapy through to one month post therapy
Secondary outcomes (6)
Core temperature
Measured using esophageal and rectal probes. Indicator of physiological heat acclimation status.
Measured: Day zero, six, and 12 of therapy
Maximum skin wettedness
Maximum skin wettedness is a measure of how much of a person's skin surface they are able to wet through sweating. In an inactive, non-heat acclimated person, a normal skin wettedness value is approximately 70%. In an active, fully-heat acclimated person, a normal skin wettedness value is approximately 100%. Skin wettedness is determined by having a person walk at a constant speed on a treadmill in a 37.5degC climate chamber, while humidity levels are progressively increased. Maximum skin wettedness is determined from the humidity level in the climate chamber at which the participant's core temperature begins to rise. The more heat acclimated a person is, the higher the humidity will get to in the room before their core temperature rises.
Measured: Day zero, six, and 12 of therapy
Blood plasma volume
Determined from venous blood draws. Indicator of physiological heat acclimation status.
Measured: Day zero, six, and 12 of therapy
Sweat rate
Both whole-body using a high-precision platform scale and locally using the ventilated capsule technic. Indicator of physiological heat acclimation status.
Measured: Day zero, six, and 12 of therapy
Skin blood flow
Determined using laser doppler flowmetry. Indicator of physiological heat acclimation status.
Measured: Day zero, six, and 12 of therapy
Reproductive hormone levels (estrogen, progesterone, luteinizing hormone, orexin)
Determined from venous blood draws. Indicator hormonal status
Measured: Day zero, six, and 12 of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2025
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Why it stopped: Unforeseen difficulties recruiting participants. Study stopped before any participants recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University
- Responsible party
- Sponsor
- Investigators
- Nathan Morris, PhD, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192329
- Sponsor's protocol ID
- 2024-029-HYBL
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hot Water Therapy for the Treatment of Menopause-related Hot Flashes and Other Symptoms: a Clinical Trial
- ClinicalTrials.gov ID
- NCT06192329
- Acronym / sponsor ID
- 2024-029-HYBL
- Conditions
- Menopause, Menopause Related Conditions, Menopause Syndrome
- Keywords
- heat therapy, hot water therapy, hot water immersion, vasomotor syndrome, hot flashes, hot flushes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unforeseen difficulties recruiting participants. Study stopped before any participants recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Collaborators
- East Carolina University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine whether hot water therapy (i.e. taking prolonged hot baths on multiple consecutive days) decreases hot flash symptoms and improves mood in women who are undergoing or who have underwent menopause. It is hypothesized that women who undergo hot water therapy will have reduced hot flash symptoms and improved mood.
Initial tracking period: Women who volunteer to participate in this study will be asked to track the frequency and intensity of their hot flash and other menopause-related symptoms for an initial two week period. Afterwards, they will start their heat therapy program.
Physiological assessments: On days 1, 7, and 13 of the heat therapy sessions, the participants will enter a climate controlled room to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min, after which the humidity in the climate chamber will be progressively increased until their core temperature begins to increase (~2 hour total time). Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (~1 tsp) blood sample will be taken, to assess how the participants respond to the heat stress. These sessions should take less than 3 hours to complete.
Hot water therapy sessions: Upon enrolling in the study, the participants will be assigned to one of two groups: water bathing at 105°F or 97°F in the lab. On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves to a water level at the shoulders for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min).
Post-intervention tracking period: after completing the heat therapy sessions, the participants will be asked to continue to take baths at home once every 4 days for 1 month. During this time, the participants will be asked to record the intensity and frequency of their hot flashes daily and other menopause-related symptoms weekly. At the end of this month the participants will be given a final exit survey, in order for them to provide the researchers information about their experience participating in the study.
Detailed description
Menopause is the time at which menstruation stops and perimenopause is the period before, characterized by a continuous reduction in estrogen and progesterone levels in the blood. Concurrently, the reductions in estrogen leads to a rise in another hormone, orexin. The reduction in circulating estrogen and progesterone and the increase in circulating orexin have been demonstrated to play a major role in menopause-related hot flashes and night sweats, known as vasomotor symptoms (VMS), as well as other symptoms such as mood disorders.
While hormonal replacement therapy remains the most effective defense against VMS, there has been a progressive decline in its prescription due to side effects such as uterine bleeding, increased risk of thromboembolism, as well as increased rates of gallbladder, breast, endometrial, and urinary cancers, highlighting the need for alternative non-hormonal treatments.
Exercise, and specifically the thermoregulatory benefits of exercise (i.e. increased sweating and skin blood flow, as well as reduced core temperature), improves vasomotor symptoms in women going through menopause. Heat acclimation/heat therapy improves thermoregulatory responses by more than twice as much as exercise alone, however, to date, no studies have investigated the effects of heat acclimation on menopause-related vasomotor symptomology.
Accordingly, the purpose of this study will be to examine whether hot water bathing improves vasomotor symptomology, with the guiding hypothesis that hot water bathing will reduce vasomotor symptomology.
Recruitment For this study, we will aim to recruit 100 women who have either undergone or who are undergoing menopause and who self-report experiencing vasomotor symptomology.
Study protocol An initial visit will be organized during which the potential participants will complete a health screening and consent to participate in the study. After which, the participants will undergo a two week-long baseline period during which they will track their vasomotor symptomology using a vasomotor symptomology journaling template, as well as complete a standardized menopause symptomology questionnaire. The participants will be randomized into two groups: a hot water bathing group and a sham group.
Following the baseline period, participants will report to the climate chamber located in the Hybl center to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min after which the humidity in the climate chamber will be progressively increased until an inflection in the participants' core temperature is detected. Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (~1 tsp) blood sample will be taken, to assess heat loss adaptations.
Next, the participants will begin their 10-day, hot water bathing sessions. The participants in the treatment group will be asked to submerge themselves in a bathtub filled with 105°F (40.5°C) water, and to remain at this depth until their esophageal temperature reaches 101.5°F (38.6°C). Based on previous hot water therapy studies using this protocol, this should take approximately 25-35 min. After attaining the target core temperature, the participants will be given a stool to sit on in order for them to remain at waist depth in the water in order to maintain their core temperature at 101.5°F (38.6°C) for an additional 60 min. Participants in the sham group will be immersed up to the shoulder in a 97°F (36°C) tub for 30 min and then to waist-level for another 60 min in order to mimic the same hydrostatic pressures as were experienced by the participants in the heat therapy group, but without the heat exposure.
Finally, following the heat therapy sessions, the participants will be asked to take hot baths at home once every four days (as this is the frequency needed to stay heat acclimated) for one month, while continuing to track their vasomotor symptomology. At the completion of this follow up period, they will complete a study exit survey that has questions regarding their experience in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm water immersion | Sham comparator | Behavioral: Warm water immersionOn days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 97°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min). |
| Hot water immersion | Experimental | Behavioral: Hot water therapyOn days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 105°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reported menopause-related hot flashes
Key exclusion criteria (1 listed)
- Diagnosed with a cardiovascular illness that precludes them from taking part in exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot water therapyAlso: heat therapy, hot water immersionOn days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 105°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min). | Behavioural | Hot water immersion |
| Warm water immersionAlso: Control trial, Sham trialOn days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 97°F water for ~30 min, followed by immersion to the hip level for ~60 min (total immersion time of 90 min). | Behavioural | Warm water immersion |
Primary outcome
Greene climacteric questionnaire
Time frame: One month pre therapy through to one month post therapy
This is a standard questionnaire used to quantify the intensity of 21 common menopause-related symptoms. The score for each question ranges in intensity from 0 (not at all) to 3 (extremely).
Daily hot flash diary
Time frame: One month pre therapy through to one month post therapy
Based on industry-standard hot flash diaries, this tracks the number and intensity (where 1 is none and 10 is extreme) of hot flashes, night sweats, and mood disruptions that the participants feel.
6 secondary outcomes
Core temperature
Time frame: Day zero, six, and 12 of therapy
Maximum skin wettedness
Time frame: Day zero, six, and 12 of therapy
Blood plasma volume
Time frame: Day zero, six, and 12 of therapy
Sweat rate
Time frame: Day zero, six, and 12 of therapy
Skin blood flow
Time frame: Day zero, six, and 12 of therapy
Reproductive hormone levels (estrogen, progesterone, luteinizing hormone, orexin)
Time frame: Day zero, six, and 12 of therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Morris, PhD principal investigator
University of Colorado, Colorado Springs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot water therapy and Warm water immersion in people with Menopause and Menopause Related Conditions, run by University of Colorado, Colorado Springs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greene climacteric questionnaire (time frame: One month pre therapy through to one month post therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.