Wrist Cooling for Hot Flashes Clinical Trial

Boston University27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hot Flashes

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Wrist Cooling for Hot Flashes Clinical Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes