Wrist Cooling for Hot Flashes Clinical Trial

NCT ID: NCT05595213

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-05
• Study Completion Date: 2025-01-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wrist Active Cooling and Placebo Device

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.

Group Type: EXPERIMENTAL

Active cooling device with cooling plate

Intervention Type: 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.

Placebo device without cooling plate

Intervention Type: DEVICE

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

Hot Flash Diary

Intervention Type: 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.

Interventions

Active cooling device with cooling plate

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.

Intervention Type: DEVICE

Placebo device without cooling plate

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

Intervention Type: DEVICE

Hot Flash Diary

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F Holick, PhD MD

Role: PRINCIPAL_INVESTIGATOR

BU School of Medicine, Endocrinology

Locations

BU School of Medicine

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-43277

Identifier Type: -

Identifier Source: org_study_id