Completed

Wrist Cooling Devices for Hot Flashes in Adults

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Study Aim

This study aims to assess if wrist cooling devices can reduce the number and severity of hot flashes in adults.

What is being tested

Active cooling device with cooling plate

+ Placebo device without cooling plate

+ Hot Flash Diary

DeviceOther
Who is being recruted

Urogenital Diseases+14

+ Genital Diseases

+ Breast Diseases

Over 21 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorBoston University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 5, 2023

Actual date on which the first participant was enrolled.

This study is exploring whether a special cooling wrist device can help reduce the severity of hot flashes in both men and women who experience them. Hot flashes can be very uncomfortable, and finding effective ways to manage them is important for improving the quality of life for those affected. The study compares the effects of an active cooling device against a placebo device that looks the same but doesn't have the cooling function. By investigating this approach, it aims to find out if wearing the cooling device can provide relief and help manage hot flash symptoms effectively. Participants in the study will wear two different wrist devices, one at a time, for two weeks each. These devices look alike so neither the participants nor the researchers know which one is being worn at any time. The active cooling device uses a fan and a cooling plate, while the placebo device only has a fan. Participants will keep a diary to record the number and severity of their hot flashes during the study. This information will help researchers determine if the active cooling device makes a noticeable difference in managing hot flashes.

Official TitlePilot Evaluation of Wrist Cooling Devices on the Severity of Hot Flashes for Women and Men Who Suffer From Moderate and or Severe Hot Flashes
Principal SponsorBoston University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBreast DiseasesBreast NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsSigns and SymptomsSkin DiseasesPathological Conditions, Signs and SymptomsUrogenital NeoplasmsSkin and Connective Tissue DiseasesHot FlashesMale Urogenital Diseases

Criteria

2 inclusion criteria required to participate
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

English speaking

5 exclusion criteria prevent from participating
Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.

Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist.

Any lack of sensitivity to coolness on the wrists or hands

Any use of pharmaceuticals or devices to treat hot flashes.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Each participant will be provided with two wrist devices \[an active cooling device and a placebo device\] that they will wear for 2 weeks each and during that time record the number of hot flashes in a study diary. The devices are worn like watches and that look identical. The order that they wear the devices will be randomly determined so some participants will wear the active cooling device first and then the placebo device and others will wear the placebo device first and then the active cooling device.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

BU School of Medicine

Boston, United StatesOpen BU School of Medicine in Google Maps
CompletedOne Study Center