Wrist Cooling for Hot Flashes Clinical Trial

Last updated: November 17, 2025
Sponsor: Boston University
Overall Status: Completed

Phase

N/A

Condition

Prostate Cancer

Urologic Cancer

Prostate Disorders

Treatment

Hot Flash Diary

Active cooling device with cooling plate

Wrist cooling device with cooling plate

Clinical Study ID

NCT05595213
H-43277
  • Ages > 21
  • All Genders

Study Summary

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.

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: 27
Treatment Group(s): 5
Primary Treatment: Hot Flash Diary
Phase:
Study Start date:
March 05, 2023
Estimated Completion Date:
January 13, 2025

Connect with a study center

  • BU School of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • BU School of Medicine

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Site Not Available

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