Hot FlashesNCT05595213
Wrist Cooling for Hot Flashes Clinical Trial
A study testing Active cooling device with cooling plate and Hot Flash Diary in people with Hot Flashes, run by Boston University at 1 site in United States.
Trial summary
This pilot study aims to determine the impact of an experimental active cooling wrist device compared to a placebo device [the devices look identical] on symptom control of hot flashes in adult men and adult women experiencing hot flashes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Active cooling device with cooling plate and Hot Flash Diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2023to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.
- Moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed
- Severe: sensation of intense heat with sweating and causing disruption of current activity
- English speaking
Who cannot join
- Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.
- Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist.
- Any lack of sensitivity to coolness on the wrists or hands
- Any use of pharmaceuticals or devices to treat hot flashes.
- Unable to understand and speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of Wrist Cooling Devices on the Severity of Hot Flashes for Women and Men Who Suffer From Moderate and or Severe Hot Flashes
This pilot study aims to determine the impact of an experimental active cooling wrist device compared to a placebo device [the devices look identical] on symptom control of hot flashes in adult men and adult women experiencing hot flashes. The participants will record during the first two weeks of the study all of their hot flashes and severity of their hot flashes in a study diary. Each participant will wear each of the two devices [active cooling and placebo] during the trial but the order of which device they wear first will be determined by their random assignment into a group. The devices are identical in appearance and neither the participant nor the investigators w ill know which device the participants are wearing. Participants will wear the first assigned device for weeks 3 and 4. They will record in their diary the severity of their hot flashes while using the device. For weeks 5 and 6 they will use a second device and record in their diary the severity of their hot flashes with the use of the device.
The devices will be attached to the wrist like a watch. When activated, the experimental active cooling device will turn on a cooling fan with the cooling plate being active for up to 5 minutes. In contrast, the placebo device will only turn on a cooling fan for up to 5 minutes without the cooling plate being active.
- Conditions
- Hot Flashes
- Being tested
- Active cooling device with cooling plate, Placebo device without cooling plate, Hot Flash Diary
- Keywords
- Breast cancer, Prostate cancer, Hormone deprivation therapy, Wrist cooling device
- Medical subject headings
- Hot Flashes, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cooling device with cooling plateDevice
This device is worn like a watch and pressing the button activates the cooling function to begin to cool the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.
Placebo device without cooling plateDevice
This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.
Hot Flash DiaryOther
Participants will be instructed to document each hot flash experience daily and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.
| Study group | Role | What they receive |
|---|---|---|
| Wrist Active Cooling and Placebo Device | Experimental | Each participant will be provided with two wrist devices [an active cooling device and a placebo device] that they will wear for 2 weeks each and during that time record the number of hot flashes in a study diary. The devices are worn like watches and that look identical. The order that they wear the devices will be randomly determined so some participants will wear the active cooling device first and then the placebo device and others will wear the placebo device first and then the active cooling device. Receives: Device: Active cooling device with cooling plate; Device: Placebo device without cooling plate; Other: Hot Flash Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Hot Flashes
Severity of hot flashes is defined as mild, moderate, and severe. The number of hot flashes by severity category are abstracted from the study 'hot flash diary'.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start5 Mar 2023
- Primary completion2 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- In this study all participants will wear both the active wrist cooling device and the placebo device that look identical. However, the order that they wear the devices \[which one they wear first or second\] will be determined randomly.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael F Holick, PhD MD, Principal investigator, BU School of Medicine, Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595213
- Sponsor's protocol ID
- H-43277
- Status last verified
- Nov 2025
- First submitted
- 21 Oct 2022
- Last updated
- 1 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Wrist Cooling Devices on the Severity of Hot Flashes for Women and Men Who Suffer From Moderate and or Severe Hot Flashes
- ClinicalTrials.gov ID
- NCT05595213
- Acronym / sponsor ID
- H-43277
- Conditions
- Hot Flashes
- Keywords
- Breast cancer, Prostate cancer, Hormone deprivation therapy, Wrist cooling device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Posted 1 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to determine the impact of an experimental active cooling wrist device compared to a placebo device [the devices look identical] on symptom control of hot flashes in adult men and adult women experiencing hot flashes. The participants will record during the first two weeks of the study all of their hot flashes and severity of their hot flashes in a study diary. Each participant will wear each of the two devices [active cooling and placebo] during the trial but the order of which device they wear first will be determined by their random assignment into a group. The devices are identical in appearance and neither the participant nor the investigators w ill know which device the participants are wearing. Participants will wear the first assigned device for weeks 3 and 4. They will record in their diary the severity of their hot flashes while using the device. For weeks 5 and 6 they will use a second device and record in their diary the severity of their hot flashes with the use of the device.
The devices will be attached to the wrist like a watch. When activated, the experimental active cooling device will turn on a cooling fan with the cooling plate being active for up to 5 minutes. In contrast, the placebo device will only turn on a cooling fan for up to 5 minutes without the cooling plate being active.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study all participants will wear both the active wrist cooling device and the placebo device that look identical. However, the order that they wear the devices [which one they wear first or second] will be determined randomly.
| Arm | Type | Receives |
|---|---|---|
| Wrist Active Cooling and Placebo Device | Experimental | Device: Active cooling device with cooling plate, Device: Placebo device without cooling plate, Other: Hot Flash DiaryEach participant will be provided with two wrist devices [an active cooling device and a placebo device] that they will wear for 2 weeks each and during that time record the number of hot flashes in a study diary. The devices are worn like watches and that look identical. The order that they wear the devices will be randomly determined so some participants will wear the active cooling device first and then the placebo device and others will wear the placebo device first and then the active cooling device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.
- English speaking
Key exclusion criteria (5 listed)
- Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.
- Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist.
- Any lack of sensitivity to coolness on the wrists or hands
- Any use of pharmaceuticals or devices to treat hot flashes.
- Unable to understand and speak English
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 |
|---|---|---|
| Active cooling device with cooling plateThis device is worn like a watch and pressing the button activates the cooling function to begin to cool the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees. | Device | Wrist Active Cooling and Placebo Device |
| Placebo device without cooling plateThis device is worn like a watch and pressing the button activates the cooling fan for 5 minutes. | Device | Wrist Active Cooling and Placebo Device |
| Hot Flash DiaryParticipants will be instructed to document each hot flash experience daily and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device. | Other | Wrist Active Cooling and Placebo Device |
Primary outcome
Number and Severity of Hot Flashes
Time frame: 6 weeks
Severity of hot flashes is defined as mild, moderate, and severe. The number of hot flashes by severity category are abstracted from the study 'hot flash diary'.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael F Holick, PhD MD principal investigator
BU School of Medicine, Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cooling device with cooling plate and Hot Flash Diary in people with Hot Flashes, run by Boston University 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 1 Dec 2025. 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. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number and Severity of Hot Flashes (time frame: 6 weeks). 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 1 Dec 2025.