Thermoregulatory Physiology of Menopausal Hot Flashes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of hot flashes
研究概览
简要总结
This study is evaluating the effects of cooling on menopausal hot flashes in midlife women. Precise targeted cooling is provided to areas of the skin when a hot flash occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age range: 40 to 65 years and in menopausal transition or post-menopause;
- •At least 8 years of education to ensure adequate reading proficiency;
- •Primary language is English or Spanish.
排除标准
- •History of medical or neurological illness or trauma that would affect the central nervous system (e.g., stroke, multiple sclerosis, epilepsy);
- •Current severe medical conditions (e.g. Diabetes, cancer, cardiovascular disease, renal or hepatic disease, thyroid disorders);
- •History of schizophrenia and/or bipolar disorder;
- •Dependence or abuse of illicit substances in the past year;
- •Current use of hormone therapy or other treatments for hot flash symptoms
研究组 & 干预措施
Sequence A-B-C
Laboratory interventions are administered in the order of Room Temperature-Ambient Cooling-Targeted skin cooling
干预措施: Intervention C (Targeted skin cooling) (Other)
Sequence A-B-C
Laboratory interventions are administered in the order of Room Temperature-Ambient Cooling-Targeted skin cooling
干预措施: Intervention B (Ambient cooling) (Other)
Sequence A-B-C
Laboratory interventions are administered in the order of Room Temperature-Ambient Cooling-Targeted skin cooling
干预措施: Intervention A (Room temperature) (Other)
Sequence B-C-A
Laboratory interventions are administered in order of Ambient cooling-Targeted skin cooling-Room temperature
干预措施: Intervention C (Targeted skin cooling) (Other)
Sequence B-C-A
Laboratory interventions are administered in order of Ambient cooling-Targeted skin cooling-Room temperature
干预措施: Intervention B (Ambient cooling) (Other)
Sequence B-C-A
Laboratory interventions are administered in order of Ambient cooling-Targeted skin cooling-Room temperature
干预措施: Intervention A (Room temperature) (Other)
Sequence C-A-B
Laboratory interventions are administered in the order of Targeted skin cooling-Room temperature-Ambient cooling
干预措施: Intervention C (Targeted skin cooling) (Other)
Sequence C-A-B
Laboratory interventions are administered in the order of Targeted skin cooling-Room temperature-Ambient cooling
干预措施: Intervention B (Ambient cooling) (Other)
Sequence C-A-B
Laboratory interventions are administered in the order of Targeted skin cooling-Room temperature-Ambient cooling
干预措施: Intervention A (Room temperature) (Other)
结局指标
主要结局
Number of hot flashes
时间窗: Across the ~5 hour experimental period in the lab
Number of hot flashes, based on sternal skin conductance measurement
次要结局
未报告次要终点