Wrist Cooling for Hot Flashes Clinical Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT05595213
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Placebo device without cooling plate — DEVICE
    This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 5, 2023
Status verified
Nov 2025
Primary completion
Jan 2, 2025
Completion
Jan 13, 2025

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number and Severity of Hot Flashes [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
BU School of MedicineBostonMassachusetts02118-

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