NCT05595213Completed
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
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 21 Oct 2022
- Start date
- 5 Mar 2023
- Primary completion date
- 2 Jan 2025
- Lead sponsor
- Boston University
- Diseases
- Prostate cancer
- NCT number
- NCT05595213
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From 5 Mar 2023 to the primary completion date, 2 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BU School of Medicine Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.