Wrist Cooling for Hot Flashes Clinical Trial

Study Overview
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Brief Summary
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This pilot randomized double blind controlled crossover study aims to determine the impact of two wrist cooling devices 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 diary. The participants will be randomly assigned to wear one of the two wrist cooling devices that have an identical appearance at different times in the study. They 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 be ask to 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, one device will turn on a cooling fan with the cooling plate being active for up to 5 minutes, and the other device will turn on a cooling fan only for up to 5 minutes without the cooling plate being active.

Detailed Description
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The randomized group will determine the order that a participant uses each device. Group 1 participants will use the wrist cooling device first for two weeks and then the fan activating device for two weeks. Group 2 participants will use the fan activating device first for two weeks followed by the wrist cooling device for two weeks. This will be a 6 week study requiring the participants to see a study team member at the beginning of the study. The participants will receive three phone calls during the study to remind them of when to use each device. They will be instructed after the 6 weeks for them to have an in person return visit and give the diaries and the devices to the study personnel. The investigators will recruit participants and conduct the study at the Boston University School of Medicine (BUSM), locally, and virtually.

Official Title
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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

Conditions
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Hot Flashes

Intervention / Treatment
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* Device: Wrist cooling device with cooling plate
* Device: Wrist fan activating device without cooling plate
* Other: Hot Flash Diary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 Wrist Cooling Devices<br>Participants randomized into Group 1 will be provided two wrist cooling devices that are worn like watches. Group 1 participants will be instructed to first use the skin cooling watch device with a cooling plate for 2 weeks and then stop using it and switch to using the watch device that activates the fan without the cooling plate for 2 weeks. | Device: Wrist cooling device with cooling plate<br>* This device is worn like a watch and pressing the button activates the cooling function to begin to col the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.<br>Device: Wrist fan activating device without cooling plate<br>* This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.<br>Other: Hot Flash Diary<br>* Participants will be instructed to daily document each hot flash experience and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.<br>|
| Experimental: Group 2 Wrist Cooling Devices<br>Participants randomized into Group 2 will be provided two wrist cooling devices that are worn like watches. Group 2 participants will be instructed to first use the cooling watch device that activates the fan without the cooling plate for 2 weeks and then stop using it and switch to using the skin cooling watch device with the cooling plate. | Device: Wrist cooling device with cooling plate<br>* This device is worn like a watch and pressing the button activates the cooling function to begin to col the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.<br>Device: Wrist fan activating device without cooling plate<br>* This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.<br>Other: Hot Flash Diary<br>* Participants will be instructed to daily document each hot flash experience and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of hot flashes severity | Participants will document the severity of hot flashes (mild, moderate, severe) in the study 'hot flash diary'. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of times wrist cooling device activated | Activation of the device will be documented by the device and by participants on the 'hot flash diary'. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Prostate cancer, Hormone deprivation therapy, Wrist cooling device