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We plan to enroll 60 healthy, non-pregnant premenopausal women age 18-45 who do not have hot flashes (in order to have 30 women complete all study procedures) in a trial investigating the impact of hot flashes developed in response to an injection of a GnRH agonist, leuprolide (brand name: Lupron) on sleep disruption and mood. This study is designed to mimic the menopause transition. Based on previous studies, we expect that 2/3 of the women will develop hot flashes, naturally dividing participants into two groups: + hot flashes and no hot flashes. We will collect data on sleep disruption and mood changes to compare differences between the + hot flashes group and the group of women who do not develop hot flashes on leuprolide.
Specific Aim 1: To determine the effects of hot flashes on sleep using a model of induced hot flashes in pre-menopausal women.
Hypothesis 1a: Hot flashes worsen objectively measured sleep
Hypothesis 1b: Exposure to hot flashes leads to the perception of poor sleep quality
Specific Aim 2: To identify the relative effects of hot flashes and sleep disruption on mood using a model of induced hot flashes in premenopausal women.
Hypothesis 2a: Objectively measured sleep disturbance has a greater effect than hot flashes on mood
Hypothesis 2b: Perception of poor sleep correlates with negative mood
Exploratory Aim: To establish the feasibility of identifying specific genetic polymorphisms for genes involved in the estrogen pathway and the development of hot flashes.
Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science
Massachusetts General Hospital
Active, not recruiting
Massachusetts General Hospital
Published on BioPortfolio: 2014-08-27T03:13:59-0400
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