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Completed

NCT Number: NCT05595213

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 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.

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Key information

Conditions

Hot Flashes Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BU School of Medicine

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.
  • Moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed
  • Severe: sensation of intense heat with sweating and causing disruption of current activity
  • English speaking

Exclusion criteria

  • Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.
  • Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist.
  • Any lack of sensitivity to coolness on the wrists or hands
  • Any use of pharmaceuticals or devices to treat hot flashes.
  • Unable to understand and speak English

Treatment and study plan

Active cooling device with cooling plate

Device

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 without cooling plate

Device

This device is worn like a watch and pressing the button activates the cooling fan for 5 minutes.

Hot Flash Diary

Other

Participants will be instructed to document each hot flash experience daily and indicate if it was mild, moderate, or severe and whether they activated the wrist cooling device.

Primary outcomes

  1. Number and Severity of Hot Flashes

    Time frame: 6 weeks

    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'.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

Pilot Evaluation of Wrist Cooling Devices on the Severity of Hot Flashes for Women and Men Who Suffer From Moderate and or Severe Hot Flashes

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2022
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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