Wrist Cooling for Hot Flashes Clinical Trial

Last updated: July 5, 2024
Sponsor: Boston University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Wrist cooling device with cooling plate

Hot Flash Diary

Wrist fan activating device without cooling plate

Clinical Study ID

NCT05595213
H-43277
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Experiencing at least 2 hot flashes per day that are either moderate and/or severein severity.

  2. Moderate: sensation of heat with sweating/dampness but able to continueactivity with only brief fanning needed

  3. Severe: sensation of intense heat with sweating and causing disruption ofcurrent activity

  4. English speaking

Exclusion

Exclusion Criteria:

  1. Temperature sensitivity due to cooling associated with an autoimmune or vasculardisorder, such as Raynaud's phenomena, peripheral arterial disease or any otherreasons.

  2. Any wrist skin sensitivity that is known to cause discomfort when any type of devicesuch 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

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Wrist cooling device with cooling plate
Phase:
Study Start date:
March 05, 2023
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • BU School of Medicine

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

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