Wrist Cooling for Hot Flashes Clinical Trial

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595213
• Other study ID #: H-43277
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2023
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Boston University
• Contact: Michael F Holick, PhD MD
• Phone: (617) 358-6139
• Email: mfholick[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
United States	BU School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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