N/A
N=27
Wrist Cooling for Hot Flashes Clinical Trial
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT05595213 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Number and Severity of Hot Flashes — 1148; 692; 924; 1213 number of hot flashes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active cooling device with cooling plate (Device); Placebo device without cooling plate (Device); Hot Flash Diary (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Severity of Hot Flashes |
1148; 692; 924; 1213; 633; 1117 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.
- 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
Data sourced from ClinicalTrials.gov (NCT05595213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.