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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active cooling device with cooling plate | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 6 weeks |
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Inclusion Criteria:
Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.
English speaking
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael F Holick, PhD MD | BU School of Medicine, Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BU School of Medicine | Boston | Massachusetts | 02118 | United States |
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Participants recorded baseline frequency and severity for 2 weeks and then were randomly assigned the order of which of the two devices they would wear first [active cooling or placebo] which they did for 2 weeks. After 2 weeks of follow up they wore the other device for 2 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Used Active Cooling Device, Then Placebo Device | The active cooling wrist device was used for 2 weeks and after 2 weeks of follow-up the placebo device was used by each participant. |
| FG001 | Used Placebo Device, Then Active Cooling Device | The placebo device was used for 2 weeks and after 2 weeks of follow-up the active cooling device was used by each participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wrist Active Cooling and Placebo Device | All participants wore both the active cooling and placebo devices for 2 weeks each. The order of which device was worn first was randomly determined. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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'. | Each participant wore an active cooling wrist device and a placebo wrist device during the study so there are data on both for each of the 27 participants. | Posted | Number | number of hot flashes | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Cooling Device, Then Placebo Device | The active cooling wrist device was used for 2 weeks and after 2 weeks of follow-up the placebo device was used by each participant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael F Holick, PhD MD | BUCA School of Medicine, Endocrinology | (617) 358-6139 | mfholick@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2024 | Nov 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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| Placebo device without cooling plate | Device | This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes. |
|
| Hot Flash Diary | Other | 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. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline number and severity of hot flashes | Number | number of hot flashes |
|
The placebo device device has the same porcelain plate that the cooling device has but it is not activated to cool when the device is turned on. This device is worn like a watch and pressing the button activates the fan for 5 minutes. |
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|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Placebo Device, Then Active Cooling Device | The placebo device was used for 2 weeks and after 2 weeks of follow-up the active cooling device was used by each participant. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |