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NCT05595213 · ClinicalTrials.gov registry record · NA
Wrist Cooling for Hot Flashes Clinical Trial
A NA study, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT05595213: Completed NA study, sponsored by Boston University.
NCT05595213 is a NA study that has completed, run by Boston University. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05595213, a NA study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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'.
Interventions
- DEVICE Active cooling device with cooling plate
- DEVICE Placebo device without cooling plate
- OTHER Hot Flash Diary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2023-03-05 |
| Est. Completion | 2025-01-13 |
| Phase | NA |
What the finished NCT05595213 record still lists
NCT05595213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Active cooling device with cooling plate is the first listed.
NCT05595213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05595213 about?
NCT05595213 is a clinical study titled "Wrist Cooling for Hot Flashes Clinical Trial". 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...
What is the current status of trial NCT05595213?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2023-03-05. Estimated completion is 2025-01-13.
What interventions are being tested in trial NCT05595213?
The interventions under investigation include: Active cooling device with cooling plate (DEVICE), Placebo device without cooling plate (DEVICE), Hot Flash Diary (OTHER).
Who is sponsoring clinical trial NCT05595213?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05595213's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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