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Wrist Cooling for Hot Flashes Clinical Trial
NA trial testing Active cooling device with cooling plate in Hot Flashes in 27 participants. Completed in 13 January 2025.
| Lead sponsor | Boston University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 5 March 2023 |
| Primary completion | 2 January 2025 |
| Estimated completion | 13 January 2025 |
| Sites | 1 location across United States |
Boston University
21 and older, any sex, with Hot Flashes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Severity of hot flashes is defined as mild, moderate, and severe. The number of hot flashes by severity category are abstracted from the study 'hot flash diary'.
| Group | Value | 95% CI |
|---|---|---|
| Active Cooling Device | 1148 | |
| Placebo Device | 692 |
| Group | Value | 95% CI |
|---|---|---|
| Active Cooling Device | 924 | |
| Placebo Device | 1213 |
| Group | Value | 95% CI |
|---|---|---|
| Active Cooling Device | 633 | |
| Placebo Device | 1117 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing