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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number and Severity of Hot Flashes
研究概览
简要总结
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.
详细描述
The randomized group will determine the order that a participant uses each device. Group 1 participants will use the wrist cooling device first for two weeks and then the fan activating device for two weeks. Group 2 participants will use the fan activating device first for two weeks followed by the wrist cooling device for two weeks.
This will be a 6 week study requiring the participants to see a study team member at the beginning of the study. The participants will receive three phone calls during the study to remind them of when to use each device. They will be instructed after the 6 weeks for them to have an in person return visit and give the diaries and the devices to the study personnel.
The investigators will recruit participants and conduct the study at the Boston University School of Medicine (BUSM), locally, and virtually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number and Severity of Hot Flashes
时间窗: 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'.
次要结局
未报告次要终点