Trial results for a study investigating a wrist cooling device for hot flashes were posted on ClinicalTrials.gov on 2025-12-01, with 27 participants enrolled.
Background
Hot flashes are a common and often disruptive symptom experienced by individuals undergoing menopause, though they can also affect men. These sudden sensations of intense heat, often accompanied by sweating and flushing, can significantly impact quality of life, sleep, and daily activities. While hormonal therapies are effective for many, some individuals seek non-pharmacological alternatives due to contraindications, personal preference, or side effects. Exploring novel, non-invasive methods for symptom control, such as wearable cooling devices, represents an area of ongoing interest in managing hot flashes.
Trial design
This completed pilot study, designated as Phase NA, enrolled 27 participants, including adult men and women experiencing hot flashes. The trial aimed to determine the impact of an experimental active cooling wrist device compared to a placebo device on the symptom control of hot flashes. Participants recorded the number and severity of their hot flashes in a study diary. Each participant wore both the active cooling and placebo devices during the trial, with the order determined by random assignment.
Key results
The trial reported several key measurements related to the number and severity of hot flashes:
- For the Active Cooling Device, recorded hot flash counts included 1148, 924, and 633 hot flashes.
- For the Placebo Device, recorded hot flash counts included 692, 1213, and 1117 hot flashes.
What this means
The posted results provide raw data on the number of hot flashes recorded for both the active cooling device and a placebo device in a pilot study involving 27 participants. Without statistical analysis or aggregation of these individual measurements, it is not possible to draw conclusions regarding the efficacy or comparative effectiveness of the active cooling wrist device for hot flash symptom control based solely on these reported numbers. This pilot data may inform the design and power calculations for future, larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05595213, titled "Wrist Cooling for Hot Flashes Clinical Trial", were posted on 2025-12-01 on clinicaltrials.gov.