Wrist Cooling Devices for Hot Flashes

Overseen By Michael F Holick, PhD MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Must not be taking: Hot flash treatments

Disqualifiers: Temperature sensitivity, Wrist skin sensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two wrist cooling devices to evaluate their effectiveness in managing hot flashes. Participants will wear these devices like watches; one device uses a cooling plate and fan, while the other uses only a fan. The goal is to determine which device more effectively reduces the severity of hot flashes. Individuals experiencing at least two moderate or severe hot flashes daily and comfortable wearing devices on their wrists may be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could enhance hot flash management.

Do I have to stop taking my current medications?

The trial requires that you stop using any pharmaceuticals or devices to treat hot flashes.

What prior data suggests that these wrist cooling devices are safe for managing hot flashes?

Research shows that wrist cooling devices are generally safe for people experiencing hot flashes. Studies have found that a wrist cooling device with a cooling plate can reduce severe hot flashes by 46%, indicating both effectiveness and good user tolerance.

Although specific safety information for the wrist fan device without the cooling plate is lacking, both types function similarly and are worn like a watch. These non-invasive devices do not enter the body, typically resulting in a lower risk of side effects.

Based on this research, wrist cooling devices for hot flashes appear to be a promising and safe option. However, as with any new treatment, participants should monitor their reactions and report any concerns to the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these wrist cooling devices for hot flashes because they offer a unique, non-hormonal approach to managing symptoms. Traditional treatments often rely on hormone replacement therapy or medications that can have side effects. These devices, worn like watches, use a novel method of direct skin cooling; one version includes a cooling plate for direct relief, while the other utilizes a fan to enhance comfort. This innovative delivery method provides a potentially safer and more convenient option for individuals seeking relief from hot flashes without the risks associated with hormonal treatments.

What evidence suggests that these wrist cooling devices are effective for hot flashes?

Research has shown that wrist cooling devices can greatly reduce hot flashes. In this trial, participants will use two different wrist cooling devices. One device, which features a cooling plate, decreased severe hot flashes by 46% and total daily hot flashes by 18%, indicating that users experienced fewer and less intense hot flashes. The wrist device that uses only a fan has not been studied as extensively, but the success of the cooling plate suggests that any cooling may help. This method appears promising for managing hot flashes in both men and women. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael F Holick, PhD MD

Principal Investigator

BU School of Medicine, Endocrinology

Are You a Good Fit for This Trial?

This trial is for adult men and women who have breast or prostate cancer, are undergoing hormone deprivation therapy, and experience at least two moderate to severe hot flashes daily. Participants must speak English and plan to continue their current therapy during the study. Those with temperature sensitivity disorders, lack of coolness sensation in wrists/hands, use of other hot flash treatments, or discomfort wearing wrist devices cannot join.

Inclusion Criteria

I experience severe hot flashes that interrupt my activities.

English speaking

I experience hot flashes that are intense but can continue my activities with brief cooling.

Exclusion Criteria

I experience discomfort when wearing devices like watches on my wrist.

I experience increased sensitivity to cold due to an autoimmune or vascular condition.

I use medication or devices to manage hot flashes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline

Participants record all hot flashes and their severity in a diary

2 weeks

1 visit (in-person)

Treatment

Participants use wrist cooling devices and record hot flash severity

4 weeks

3 phone calls

Follow-up

Participants return devices and diaries to study personnel

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Wrist Cooling Device with Cooling Plate
• Wrist Fan Activating Device without Cooling Plate

Trial Overview

The study tests two wrist-worn cooling devices: one with a cooling plate and fan, the other with just a fan. Over six weeks, participants will wear each device for two weeks while recording hot flash severity in a diary. The goal is to see if there's a difference in relief between the two devices.

How Is the Trial Designed?

Group I: Wrist Active Cooling and Placebo Device Experimental Treatment 3 Interventions

Each participant will be provided with two wrist devices \[an active cooling device and a placebo device\] that they will wear for 2 weeks each and during that time record the number of hot flashes in a study diary. The devices are worn like watches and that look identical. The order that they wear the devices will be randomly determined so some participants will wear the active cooling device first and then the placebo device and others will wear the placebo device first and then the active cooling device.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Published Research Related to This Trial

Hot flashes affect 75% of perimenopausal and menopausal women, with severity linked to factors like body composition and smoking history, indicating a complex interplay of hormonal and lifestyle influences.

The most effective treatments for hot flashes are hormone replacement therapies with estrogen and progesterone, while alternative therapies lack robust scientific support, highlighting the importance of evidence-based approaches in managing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The perimenopausal hot flash: epidemiology, physiology, and treatment. Shaw, CR.[2005]

Conventional criteria for classifying hot flashes in menopausal women showed poor sensitivity (41%) and variable performance, particularly in women with higher body mass index or anxiety.

In contrast, Support Vector Machines (SVM), an advanced machine learning method, significantly improved classification accuracy with a sensitivity of 89% and specificity of 96%, suggesting that SVM could enhance the detection of hot flashes using skin conductance measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the performance of physiologic hot flash measures with support vector machines. Thurston, RC., Matthews, KA., Hernandez, J., et al.[2021]

Head cooling (HC) did not effectively reduce body temperature or perceived strain during firefighting drills, indicating it may not be a beneficial intervention for firefighters in active conditions.

Forearm cooling (FC) significantly lowered gastrointestinal temperature and physiological strain during rehabilitation intervals, suggesting it is a useful strategy for recovery after firefighting activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and Perceived Effects of Forearm or Head Cooling During Simulated Firefighting Activity and Rehabilitation. Yeargin, S., McKenzie, AL., Eberman, LE., et al.[2018]

During hot flashes in a menopausal woman, internal body temperatures dropped significantly, with the lowest recorded at 35.2°C in the tympanic area, indicating a unique physiological response to these episodes.

The study suggests that hot flashes are characterized by a rapid increase in peripheral temperatures (like fingers and toes) and a subsequent drop, with relief achieved through cooling methods, such as applying cold water to the cheeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body temperatures during menopausal hot flashes. Molnar, GW.[2017]

In a study of 156 patients undergoing oral and maxillofacial surgery, post-operative cooling at 18°C resulted in significantly less residual swelling on the 30th post-operative day compared to cooling at 22°C.

Both cooling temperatures resulted in similar levels of post-operative pain, but patients in the 18°C group reported a more agreeable treatment experience overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, prospective trial to assess the safety and efficacy of hilotherapy in patients after orthognathic surgery. Bonitz, L., El-Karmi, A., Linssen, J., et al.[2022]

Hot flashes, a common symptom during menopause, are linked to changes in the hypothalamic thermoregulatory center due to estrogen withdrawal, leading to a lower temperature set point.

Estrogen therapy is an effective and safe treatment for hot flashes, benefiting most women while also providing protective effects against heart disease and osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The hot flash: pathophysiology and treatment. Frishman, GN.[2005]

Rapid cooling is crucial for managing heat-stroke, as prolonged hyperpyrexia can lead to poor patient outcomes.

Evaporative cooling has been identified as the most efficient method for cooling, supported by both military and civilian experiences, and should be prioritized in treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat-stroke: a review of rapid cooling techniques. Harker, J., Gibson, P.[2019]

A 4-week study involving 39 perimenopausal and postmenopausal women showed that using a warming/cooling wrist device significantly improved sleep onset and increased overall nighttime sleep, reducing insomnia symptoms.

Participants reported a notable decrease in the interference of hot flashes with sleep, with 49% feeling more in control of their sleep disruption while using the device, indicating its potential as an effective intervention for managing nighttime thermal discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal Comfort Intervention for Hot-flash Related Insomnia Symptoms in Perimenopausal and Postmenopausal-aged Women: An Exploratory Study. Composto, J., Leichman, ES., Luedtke, K., et al.[2021]

A study using a human arm to test different cooling temperatures during light treatments showed that even a small change of 8 degrees Celsius in cooling temperature can significantly affect the amount of epidermal crusting, with higher temperatures leading to less crusting.

The findings suggest that proper epidermal cooling is crucial for safer light-based skin treatments, as it can minimize adverse effects and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of temperature-controlled cooling on light-based skin treatments. Goldberg, DJ.[2006]

In a study of 42 comatose cardiac arrest survivors, using an endovascular cooling catheter provided better control of maintaining the target hypothermia temperature (33 degrees C) compared to simple surface cooling methods, which often led to temperature overshoot.

While both methods achieved similar rates of active cooling, the larger endovascular catheter (14 F) was associated with faster cooling rates, suggesting it may enhance the effectiveness of hypothermia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia after cardiac arrest: performance characteristics and safety of surface cooling with or without endovascular cooling. Flint, AC., Hemphill, JC., Bonovich, DC.[2018]

The CAERvest® cooling device effectively reduced body temperature in healthy individuals, with the most significant reductions observed using the proof of concept and prototype 3 models, showing potential for treating heat-related conditions.

No cold-related injuries were reported during the study, indicating that the CAERvest® is a safe option for cooling without adverse effects, warranting further research in both healthy and clinical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAERvest® - a novel endothermic hypothermic device for core temperature cooling: safety and efficacy testing. Willmott, AGB., Bliss, A., Simpson, WH., et al.[2019]

A study involving 8 participants tested a portable cooling device for firefighters, showing that it significantly reduced rectal temperature during recovery after exercise in a heated environment.

The cooling device was 144% more effective than passive recovery methods in lowering body temperature, which can enhance safety and performance for firefighters working in hot conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new hand-cooling device to enhance firefighter heat strain recovery. Zhang, Y., Bishop, PA., Casaru, C., et al.[2019]

The Arctic Sun Temperature Management System effectively induced therapeutic hypothermia in cardiac arrest survivors, achieving the target temperature of 32-34 °C within an average of 2.78 hours for 80% of patients.

While minor skin injuries occurred in 20% of patients, these were primarily linked to shock and low left ventricular ejection fraction, indicating that careful monitoring is needed for at-risk patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surface cooling after cardiac arrest: effectiveness, skin safety, and adverse events in routine clinical practice. Jarrah, S., Dziodzio, J., Lord, C., et al.[2021]

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Study Finds Wrist Cooling Represents a Promising ...

The data shows that the KÜLKUF device significantly reduced severe hot flashes by 46% (p<0.02) and total daily hot flashes by 18% relative ...

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Wrist cooling could help managing hot flash study finds

A cooling wristband device was found to reduce severe hot flash episodes by 46 per cent in breast cancer patients, prostate cancer patients ...

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New Study Highlights Wrist Cooling as a Promising Method ...

The results were nothing short of remarkable. Utilization of the active wrist cooling device yielded a striking 46% reduction in severe hot ...

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Novel Wrist Cooling Device Can Help Manage Hot Flashes

The active cooling intervention reduced severe hot flash episodes by 46% (95% CI, 18%-74%) and total daily hot flashes by 18% (95% CI, 2%-34%) ...

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Study finds wrist cooling represents a promising approach ...

The researchers observed a 46% reduction in severe hot flash episodes. Subset analysis revealed a 41% reduction in severe episodes in breast ...

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Embr Wave Cooling Bracelet - Warming Bracelet

TAKE CONTROL OF HOT FLASHES* - Clinically proven to be a safe and effective solution for managing hot flashes, chills, night sweats, and disrupted sleep.

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This pilot randomized double blind controlled crossover study aims to determine the impact of two wrist cooling devices on symptom control of hot flashes in ...

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Embr Wave 2 Review | Hot Flashes and Night Sweats

A device akin to a smartwatch that uses cooling and warming sensations to lessen the effects of hot flashes, improve sleep, and ease stress.