Impact of Hot Flashes on Sleep and Mood Disturbance
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.
|Study Design:||Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance|
- Change in sleep efficiency from pre- to post-GnRH agonist administration [ Time Frame: Two PSG studies at baseline and two PSG studies at study end, 4 weeks after GnRH agonist administration ] [ Designated as safety issue: No ]Sleep efficiency will be calculated by averaging the two PSG studies at each time point.
- Average daily number of subjectively reported hot flashes (hot flash diary) [ Time Frame: 4th week after GnRH agonist is given ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: GnRH Agonist Injection
We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.
Leuprolide acetate 3.75-mg intramuscular injection
Leuprolide is a widely used GnRH agonist. Leuprolide is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women.
Leuprolide can induce amenorrhea for 2-3 months after a depot injection is given. However, unpredictable menstrual bleeding and spotting can occur during this time period. Menstrual-cycle patterns will be monitored closely during the study. Although long-term administration of any GnRH agonist (i.e., >6 months) is associated with bone loss, bone effects are not expected in this protocol because GnRH agonist therapy will be used for only one month.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Hadine Joffe, MD||Massachusetts General Hospital|