Wrist Cooling Devices for Hot Flashes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University
Must not be taking: Hot flash treatments
Disqualifiers: Temperature sensitivity, Wrist skin sensitivity, others
No Placebo Group
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.
12345What 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.
24678Is 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.
910111213Eligibility 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.
+1 more
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.
+2 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Group 2 Wrist Cooling DevicesExperimental Treatment3 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 DevicesExperimental Treatment3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BU School of MedicineBoston, MA
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Who Is Running the Clinical Trial?
Boston UniversityLead Sponsor
References
Therapeutic hypothermia after cardiac arrest: performance characteristics and safety of surface cooling with or without endovascular cooling. [2018]Various methods are available to induce and maintain therapeutic hypothermia after cardiac arrest, but little data is available comparing device-mediated cooling to simple surface methods in this setting.
Physiological and Perceived Effects of Forearm or Head Cooling During Simulated Firefighting Activity and Rehabilitation. [2018]Cooling devices aim to protect firefighters by attenuating a rise in body temperature. Devices for head cooling (HC) while firefighting and forearm cooling (FC) during rehabilitation (RHB) intervals are commonly marketed, but research regarding their efficacy is limited.
Heat-stroke: a review of rapid cooling techniques. [2019]Patients with prolonged hyperpyrexia due to heat-stroke have a poor outcome. Thus, the most important feature in the management of heat-stroke is rapid cooling. There are several methods of cooling available, such as fan therapy, cold water immersion, iced baths and evaporative cooling. Based on military and civilian experiences worldwide the development of protocols based on evaporative cooling is advocated as the most efficient.
A new hand-cooling device to enhance firefighter heat strain recovery. [2019]This study tested a new portable cooling device for fire fighting recovery. Participants (N = 8) walked and did arm curls (time-weighted VO(2): 1.6 L x min(-1) on a treadmill for 40 min in a heated chamber (wet bulb globe temperature: 33.7 degrees C; relative humidity: 40-45%) while wearing firefighter turn-out gear and self-contained breathing apparatus (SCBA). Immediately on finishing exercise, participants recovered for 40 min with either a hand-cooling device or seated passive recovery at an ambient temperature of 22 degrees C, 35% RH in a repeated-measures counterbalanced design. The cooling device had little impact on recovery during the first 30 min; however, compared with passive cooling, the cooling device resulted in significantly lower rectal temperature (T(re)) during the last 10 min. Relative to starting T(re) of the recovery period, Delta T(re) at 35 min had fallen 0.51 +/- 0.19 degrees C (passive) and 0.76 +/- 0.30 degrees C (active) (p = 0.03); and at 40 min Delta T(re) had fallen 0.63 +/- 0.17 degrees C (passive) and 0.88 +/- 0.31 degrees C (active) (p = 0.03). Cooling capacity of the device calculated from Delta T(re) over the whole recovery period averaged about 144% of passive. Reductions in heat storage enhance worker safety and performance in hot environments.
A randomized, prospective trial to assess the safety and efficacy of hilotherapy in patients after orthognathic surgery. [2022]A post-operative cooling method in oral and maxillofacial surgery is the cooling with hilotherapy. The aim of this study was the post-operative comparison of cooling temperatures of 18°C and 22°C. The parameters of this trial were swelling and the post-operative pain levels.
CAERvest® - a novel endothermic hypothermic device for core temperature cooling: safety and efficacy testing. [2019]Cooling of the body is used to treat hyperthermic individuals with heatstroke or to depress core temperature below normal for neuroprotection. A novel, chemically activated, unpowered cooling device, CAERvest®, was investigated for safety and efficacy.
Effect of temperature-controlled cooling on light-based skin treatments. [2006]A variety of cooling devices are used to provide safe and effective light based treatments of the skin. Despite the documented safety of such cooling devices, there is scant data on the epidermal effects of different cooling temperatures when used with such technologies.
Surface cooling after cardiac arrest: effectiveness, skin safety, and adverse events in routine clinical practice. [2021]Effectiveness of cooling and adverse events (AEs) involving skin have not been intensively evaluated in cardiac arrest survivors treated with therapeutic hypothermia (TH) when induced and maintained with a servomechanism-regulated surface cooling system.
Improving the performance of physiologic hot flash measures with support vector machines. [2021]Hot flashes are experienced by over 70% of menopausal women. Criteria to classify hot flashes from physiologic signals show variable performance. The primary aim was to compare conventional criteria to Support Vector Machines (SVMs), an advanced machine learning method, to classify hot flashes from sternal skin conductance. Thirty women with > or =4 hot flashes/day underwent laboratory hot flash testing with skin conductance measurement. Hot flashes were quantified with conventional (> or =2 micromho, 30 s) and SVM methods. Conventional methods had poor sensitivity (sensitivity=0.41, specificity=1, positive predictive value (PPV)=0.94, negative predictive value (NPV)=0.85) in classifying hot flashes, with poorest performance among women with high body mass index or anxiety. SVM models showed improved performance (sensitivity=0.89, specificity=0.96, PPV=0.85, NPV=0.96). SVM may improve the performance of skin conductance measures of hot flashes.
The perimenopausal hot flash: epidemiology, physiology, and treatment. [2005]The "hot flash" (HF), or vasomotor instability, is experienced by 75% of perimenopausal and menopausal women in the United States. The experience for some women is a minor annoyance but for others, the HF is an intensely unpleasant sensation that is disruptive to their lives. The HF is thought to be triggered by a number of external and internal stimuli such as anxiety, stress, ambient high temperatures, caffeine, and alcohol. The thinner woman tends to experience more severe and frequent HFs than the woman with more adipose tissue, probably because of the ability of adipose tissue to transform androstenedione to estrone and estradiol. Smoking history also tends to be associated with the experience of HFs at an earlier age. The etiology of HFs in the decreasing estrogen state is related to the downward resetting of the hypothalamic thermoregulating mechanism, probably by the action of norepinephrine, which is usually modulated by estrogen. The body attempts to dissipate unwanted body heat by vasodilation, thus causing the sensation of the HF. The most successful treatment modalities have been hormone replacement therapy with estrogen and progesterone. Alpha 2-adrenergic blockers have also shown some limited effectiveness. Many alternative therapies such as vitamin E, primrose oil, dong quai, and black cohash have anecdotal support but have not been thoroughly studied. Relaxation, exercise, avoidance of triggering factors, and control of external environment have all been utilized with some success by women.
Body temperatures during menopausal hot flashes. [2017]Body temperatures during hot flashes were measured in a menopausal woman. Internal temperatures fell after each flash; lowest: rectal, 35.6 degrees C; vaginal, 35.6 degrees C; tympanic, 35.2 degrees C. Where sweating occurred, the skin temperature fell during the flash and rose after it. Finger and toe temperatures always showed a sharp rise at the onset of a flash with a slower fall after the flash. Only the cheeks showed additional temperature rises; maximum, 0.7 degrees C. The heart accelerated 13% at the onset of the flash but slowed immediately thereafter. The flash interval was sharply demarcated by undulations in the ECG baseline. There was never any premonitory sign of the imminence of a flash. A central excitatory state seemed to build up, perhaps by the accumulation of a chemical compound, but not of heat, which was explosively dischargedmthe thermal distress was probably evoked by vascular warming in the cheeks. Dabbing the malar prominences with cold water brought prompt relief.
The hot flash: pathophysiology and treatment. [2005]Hot flashes are the most frequent somatic complaint of women going through the menopause. Although the exact pathophysiology of the hot flash remains unknown, it appears to be related to an alteration in the set point of the hypothalamic thermoregulatory center. With the withdrawal of estrogen, some event parallel to the release of GnRH (and subsequent release of LH) causes a decrease in the set point of the thermoregulatory center. The hot flash, with its characteristic sweating and vasodilation, represents the attempt to decrease the body core temperature and restore equilibrium. Estrogen therapy reliably treats hot flashes in the majority of women in addition to its proven beneficial effect on heart disease and osteoporosis. It is rare that health care providers can so reliably and safely positively impact on a patient's symptoms and overall health.
Thermal Comfort Intervention for Hot-flash Related Insomnia Symptoms in Perimenopausal and Postmenopausal-aged Women: An Exploratory Study. [2021]Objective/Background: To examine a novel intervention for nighttime thermal comfort and sleep of perimenopausal- and postmenopausal-aged women who experience hot flashes and insomnia symptoms. Participants: Thirty-nine women (ages 45-58, M = 52.1 years) with sleep-disrupting hot flashes and insomnia symptoms. Methods: This was a 4-week randomized cross-over study. The intervention included 2 weeks of nighttime use of a warming/cooling device worn on the wrist and was compared to a 2-week baseline period (no device). All participants completed questionnaires at the end of each 2-week period, including the Insomnia Severity Index, the PROMIS Sleep Disturbance and Sleep-Related Impairment scales, Epworth Sleepiness Scale, and the Hot Flash Related Daily Interference Scale. Results: The intervention resulted in a reduction in sleep onset latency, as well as an increase in nighttime sleep. There was a significant improvement of scores on the Insomnia Severity Index, PROMIS Sleep Disturbance and Sleep-Related Impairment scales, and the Epworth Sleepiness Scale. Significantly fewer women reported that hot flashes interfered with their sleep (90% vs 70%) and more perceived control over the degree of sleep disruption due to nighttime hot flashes while using the device (5% vs 49%). The majority reported a positive experience, with two-thirds reporting that the device improved their thermal comfort and ability to return to sleep after a night waking. Conclusions: Overall, a thermal comfort intervention may offer sleep benefits for women who experience disruptive nighttime hot flashes, particularly in terms of falling asleep at bedtime and subjective perception of control over nighttime hot flash sleep interference.