Trial Outcomes & Findings for Wrist Cooling for Hot Flashes Clinical Trial (NCT NCT05595213)

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-12-01

Participant Flow

Participants recorded baseline frequency and severity for 2 weeks and then were randomly assigned the order of which of the two devices they would wear first \[active cooling or placebo\] which they did for 2 weeks. After 2 weeks of follow up they wore the other device for 2 weeks.

Participant milestones

Participant milestones
Measure	Used Active Cooling Device, Then Placebo Device The active cooling wrist device was used for 2 weeks and after 2 weeks of follow-up the placebo device was used by each participant.	Used Placebo Device, Then Active Cooling Device The placebo device was used for 2 weeks and after 2 weeks of follow-up the active cooling device was used by each participant.
Overall Study STARTED	12	15
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wrist Active Cooling and Placebo Device n=27 Participants All participants wore both the active cooling and placebo devices for 2 weeks each. The order of which device was worn first was randomly determined.
Age, Continuous	58.6 years STANDARD_DEVIATION 15.7 • n=27 Participants
Sex: Female, Male Female	15 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants
Baseline number and severity of hot flashes Mild	785 number of hot flashes n=27 Participants
Baseline number and severity of hot flashes Moderate	1317 number of hot flashes n=27 Participants
Baseline number and severity of hot flashes Severe	1195 number of hot flashes n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Each participant wore an active cooling wrist device and a placebo wrist device during the study so there are data on both for each of the 27 participants.

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'.

Outcome measures

Outcome measures
Measure	Active Cooling Device n=27 Participants This device is worn like a watch and pressing the button activates the cooling function to begin to cool the wrist skin temperature to 47 degrees. Pushing the device button again cools the skin to 60 degrees and a third time to 77degrees.	Placebo Device n=27 Participants The placebo device device has the same porcelain plate that the cooling device has but it is not activated to cool when the device is turned on. This device is worn like a watch and pressing the button activates the fan for 5 minutes.
Number and Severity of Hot Flashes Mild	1148 number of hot flashes	692 number of hot flashes
Number and Severity of Hot Flashes Moderate	924 number of hot flashes	1213 number of hot flashes
Number and Severity of Hot Flashes Severe	633 number of hot flashes	1117 number of hot flashes

Adverse Events

Active Cooling Device, Then Placebo Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Device, Then Active Cooling Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael F Holick, PhD MD

BUCA School of Medicine, Endocrinology

Phone: (617) 358-6139

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place