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Trial Title:
Wrist Cooling for Hot Flashes Clinical Trial
NCT ID:
NCT05595213
Condition:
Hot Flashes
Conditions: Official terms:
Hot Flashes
Conditions: Keywords:
Breast cancer
Prostate cancer
Hormone deprivation therapy
Wrist cooling device
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Device
Intervention name:
Wrist cooling device with cooling plate
Description:
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.
Arm group label:
Group 1 Wrist Cooling Devices
Arm group label:
Group 2 Wrist Cooling Devices
Intervention type:
Device
Intervention name:
Wrist fan activating device without cooling plate
Description:
This device is worn like a watch and pressing the button activates the cooling fan for 5
minutes.
Arm group label:
Group 1 Wrist Cooling Devices
Arm group label:
Group 2 Wrist Cooling Devices
Intervention type:
Other
Intervention name:
Hot Flash Diary
Description:
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.
Arm group label:
Group 1 Wrist Cooling Devices
Arm group label:
Group 2 Wrist Cooling Devices
Summary:
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:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Experiencing at least 2 hot flashes per day that are either moderate and/or severe
in severity.
1. Moderate: sensation of heat with sweating/dampness but able to continue
activity with only brief fanning needed
2. Severe: sensation of intense heat with sweating and causing disruption of
current activity
2. English speaking
Exclusion Criteria:
1. Temperature sensitivity due to cooling associated with an autoimmune or vascular
disorder, such as Raynaud's phenomena, peripheral arterial disease or any other
reasons.
2. Any wrist skin sensitivity that is known to cause discomfort when any type of device
such as a wristwatch is placed on the wrist.
3. Any lack of sensitivity to coolness on the wrists or hands
4. Any use of pharmaceuticals or devices to treat hot flashes.
5. Unable to understand and speak English
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BU School of Medicine
Address:
City:
Boston
Zip:
02118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael F Hollick, PhD MD
Phone:
617-358-6139
Email:
mfholick@bu.edu
Start date:
March 5, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Boston University
Agency class:
Other
Source:
Boston University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05595213
