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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116401
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Hadine Joffe, MD||Massachusetts General Hospital|