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

29 Participants Needed

Trial Summary

What is the purpose of this trial?

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 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 diary. The participants will be randomly assigned to wear one of the two wrist cooling devices that have an identical appearance at different times in the study. They 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 be ask to 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, one device will turn on a cooling fan with the cooling plate being active for up to 5 minutes, and the other device will turn on a cooling fan only for up to 5 minutes without the cooling plate being active.

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 data supports the idea that Wrist Cooling Devices for Hot Flashes is an effective treatment?

The available research does not provide specific data on the effectiveness of Wrist Cooling Devices for Hot Flashes. The studies mentioned focus on cooling methods for other conditions, such as recovery for firefighters and post-surgery cooling, but do not directly address hot flashes. Therefore, there is no direct evidence from the provided information to support the effectiveness of Wrist Cooling Devices for Hot Flashes. ^{1 2 3 4 5}

What safety data exists for wrist cooling devices for hot flashes?

The provided research does not directly address the safety of wrist cooling devices for hot flashes. The studies focus on different cooling devices and contexts, such as firefighter recovery, skin treatments, and therapeutic hypothermia, without specific mention of wrist cooling devices for hot flashes. Therefore, no specific safety data for this treatment is available from the given research. ^{2 4 6 7 8}

Is the wrist cooling device a promising treatment for hot flashes?

Yes, the wrist cooling device is a promising treatment for hot flashes. It helps improve sleep by reducing the time it takes to fall asleep and increasing overall nighttime sleep. Many women reported feeling more in control of their sleep disruptions caused by hot flashes and experienced better thermal comfort, making it easier to return to sleep after waking up at night. ^{9 10 11 12 13}

Research Team

Michael F Holick, PhD MD

Principal Investigator

BU School of Medicine, Endocrinology

Eligibility Criteria

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

English speaking

I experience 2 or more moderate to severe hot flashes daily.

Exclusion Criteria

Unable to understand and speak English

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Group 2 Wrist Cooling Devices Experimental Treatment 3 Interventions

Participants randomized into Group 2 will be provided two wrist cooling devices that are worn like watches. Group 2 participants will be instructed to first use the cooling watch device that activates the fan without the cooling plate for 2 weeks and then stop using it and switch to using the skin cooling watch device with the cooling plate.

Group II: Group 1 Wrist Cooling Devices Experimental Treatment 3 Interventions

Participants randomized into Group 1 will be provided two wrist cooling devices that are worn like watches. Group 1 participants will be instructed to first use the skin cooling watch device with a cooling plate for 2 weeks and then stop using it and switch to using the watch device that activates the fan without the cooling plate for 2 weeks.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia after cardiac arrest: performance characteristics and safety of surface cooling with or without endovascular cooling. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Physiological and Perceived Effects of Forearm or Head Cooling During Simulated Firefighting Activity and Rehabilitation. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Heat-stroke: a review of rapid cooling techniques. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A new hand-cooling device to enhance firefighter heat strain recovery. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

A randomized, prospective trial to assess the safety and efficacy of hilotherapy in patients after orthognathic surgery. [2022]

6. England pubmed.ncbi.nlm.nih.gov

CAERvest® - a novel endothermic hypothermic device for core temperature cooling: safety and efficacy testing. [2019]

7. England pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Surface cooling after cardiac arrest: effectiveness, skin safety, and adverse events in routine clinical practice. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Improving the performance of physiologic hot flash measures with support vector machines. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Body temperatures during menopausal hot flashes. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

The hot flash: pathophysiology and treatment. [2005]

13. England pubmed.ncbi.nlm.nih.gov

Thermal Comfort Intervention for Hot-flash Related Insomnia Symptoms in Perimenopausal and Postmenopausal-aged Women: An Exploratory Study. [2021]