Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Percent Change in Wake After Sleep Onset (WASO)
研究概览
简要总结
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-45 years old
- •Premenopausal
- •Willingness to use barrier methods of contraception during study and after completion of study until menses resume
- •Good general health
排除标准
- •Pregnancy or currently breastfeeding
- •Hot flushes
- •Mid-luteal phase progesterone <3ng/mL
- •Clinically significant abnormalities in screening blood tests
- •BMI > 35 kg/m2
- •Previously diagnosed osteoporosis or osteopenia
- •Clinically significant depressive symptoms
- •Psychiatric illness
- •Sleep apnea or periodic limb movement of sleep (PLMS)
- •Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
- •Current or recent use of centrally active medications
- •Current or recent use of systemic hormone medications
- •Night shift workers
- •Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood
- •Abnormal vaginal bleeding
- •History of any medical diseases that may put subject at risk when treated with study medication.
研究组 & 干预措施
GnRH Agonist Injection
We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.
干预措施: leuprolide (Drug)
结局指标
主要结局
Percent Change in Wake After Sleep Onset (WASO)
时间窗: baseline and 4 weeks
Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.
次要结局
- Change in Montgomery-Asperg Depression Rating Scale (MADRS)(baseline and 4 weeks)
研究者
Hadine Joffe, MD
Vice Chair for Psychiatry Research
Brigham and Women's Hospital