Wrist Cooling for Hot Flashes Clinical Trial

Pilot Evaluation of Wrist Cooling Devices on the Severity of Hot Flashes for Women and Men Who Suffer From Moderate and or Severe Hot Flashes

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.

Study Overview

• Status: Recruiting
• Conditions: Hot Flashes
• Intervention / Treatment: Other: Hot Flash Diary; Device: Wrist cooling device with cooling plate; Device: Wrist fan activating device without cooling plate

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael F Holick, PhD MD; Phone Number: (617) 358-6139; Email: mfholick@bu.edu
• Study Contact Backup: Name: Nazli Ucar, MS; Phone Number: (617) 358-6139; Email: nucar@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • BU School of Medicine
      • Contact: Michael F Hollick, PhD MD; Phone Number: 617-358-6139; Email: mfholick@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Wrist Cooling Devices; Participants randomized into Group 1 will be provided two wrist cooling devices that are worn like watches. Group 1 participants will be instructed to first use the skin cooling watch device with a cooling plate for 2 weeks and then stop using it and switch to using the watch device that activates the fan without the cooling plate for 2 weeks.	Other: Hot Flash Diary; Participants will be instructed to daily document each hot flash experience and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.; Device: Wrist cooling device with cooling plate; This device is worn like a watch and pressing the button activates the cooling function to begin to col the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.; Device: Wrist fan activating device without cooling plate; This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.
Experimental: Group 2 Wrist Cooling Devices; Participants randomized into Group 2 will be provided two wrist cooling devices that are worn like watches. Group 2 participants will be instructed to first use the cooling watch device that activates the fan without the cooling plate for 2 weeks and then stop using it and switch to using the skin cooling watch device with the cooling plate.	Other: Hot Flash Diary; Participants will be instructed to daily document each hot flash experience and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.; Device: Wrist cooling device with cooling plate; This device is worn like a watch and pressing the button activates the cooling function to begin to col the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.; Device: Wrist fan activating device without cooling plate; This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of hot flashes severity	Participants will document the severity of hot flashes (mild, moderate, severe) in the study 'hot flash diary'.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times wrist cooling device activated	Activation of the device will be documented by the device and by participants on the 'hot flash diary'.	6 weeks

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Michael F Holick, PhD MD, BU School of Medicine, Endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Prostate cancer; Hormone deprivation therapy; Wrist cooling device
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: H-43277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes