Wrist Cooling for Hot Flashes Clinical Trial

NCT05595213 | Completed Results FDA Device

• 1 other identifier: H-43277
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hot Flashes

Keywords

Breast cancer; Prostate cancer; Hormone deprivation therapy; Wrist cooling device

Outcome Measures

Primary Outcomes (1)

• Number and Severity of Hot Flashes

  Severity of hot flashes is defined as mild, moderate, and severe. The number of hot flashes by severity category are abstracted from the study 'hot flash diary'.

  6 weeks

Study Arms (1)

Wrist Active Cooling and Placebo Device

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.

Device: Active cooling device with cooling plate; Device: Placebo device without cooling plate; Other: Hot Flash Diary

Interventions

Active cooling device with cooling plate DEVICE

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.

Wrist Active Cooling and Placebo Device

Placebo device without cooling plate DEVICE

This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.

Wrist Active Cooling and Placebo Device

Hot Flash Diary OTHER

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.

Wrist Active Cooling and Placebo Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.
• Moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed
• Severe: sensation of intense heat with sweating and causing disruption of current activity
• English speaking

You may not qualify if:

• 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.
• Unable to understand and speak English

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

BU School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Michael F Holick, PhD MD
• Organization: BUCA School of Medicine, Endocrinology

mfholick@bu.edu

(617) 358-6139

Study Officials

• Michael F Holick, PhD MD

  BU School of Medicine, Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study all participants will wear both the active wrist cooling device and the placebo device that look identical. However, the order that they wear the devices \[which one they wear first or second\] will be determined randomly.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: March 5, 2023
• Primary Completion: January 2, 2025
• Study Completion: January 13, 2025
• Last Updated: December 1, 2025
• Results First Posted: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)