Hot Flashes Clinical Trial
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
NCT number | NCT05595213 |
Other study ID # | H-43277 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 5, 2023 |
Est. completion date | July 2024 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | BU School of Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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