Advertisement

Topics

Impact of Hot Flashes on Sleep and Mood Disturbance

2014-08-27 03:13:59 | BioPortfolio

Summary

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

Conditions

Menopause

Intervention

Leuprolide

Location

Massachusetts General Hospital
Boston
Massachusetts
United States
02114

Status

Active, not recruiting

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

Clinical Trials [221 Associated Clinical Trials listed on BioPortfolio]

Menopausal Sleep Fragmentation and Body Fat Gain

This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmenta...

Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism

OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian ...

Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer

The purpose of this research study is to determine the effects of abiraterone acetate plus leuprolide acetate and prednisone versus leuprolide acetate alone on hormone levels in the blood ...

A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty

The purpose of this study is to determine if new formulations (11.25 and 30 mg) of leuprolide are effective in treating children with Central Precocious Puberty.

Leuprolide in Determining the Cause of Gonadotropin Deficiency

RATIONALE: The body's response to one injection of leuprolide may provide more information than the standard test for gonadotropin deficiency in determining whether the cause of gonadotrop...

PubMed Articles [224 Associated PubMed Articles listed on BioPortfolio]

The influence of unilateral oophorectomy on the age of menopause.

To determine the age of menopause after premenopausal unilateral oophorectomy (UO) and to establish whether UO at a young age leads to menopause at a younger age than if UO occurs at an older age.

Type of Menopause, Age at Menopause, and Risk of Developing Obstructive Sleep Apnea in Postmenopausal Women.

Despite established sex differences and longstanding hypotheses of sex hormones in obstructive sleep apnea (OSA) etiology, no studies have evaluated type of menopause and age at menopause, which affec...

Age at natural menopause and its associated factors in Canada: cross-sectional analyses from the Canadian Longitudinal Study on Aging.

Early onset of menopause is associated with long-term disease and higher mortality risks. Research suggests that age at natural menopause (ANM) varies across populations. Little is known about factors...

Evaluating the content and development of decision aid tools for the management of menopause: A scoping review.

Decision-making during menopause (especially surgical menopause) can be complex given the variability in risk-benefit perceptions of menopausal treatments. Decision aid tools (DATs) help women partici...

GP registrar consultations addressing menopause-related symptoms: a cross-sectional analysis.

To investigate the prevalence and associations of general practitioner registrars' (trainees') management of women with menopause-related symptoms.

Medical and Biotech [MESH] Definitions

The transitional period before and after MENOPAUSE. Perimenopausal symptoms are associated with irregular MENSTRUAL CYCLE and widely fluctuated hormone levels. They may appear 6 years before menopause and subside 2 to 5 years after menopause.

Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.

The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age.

The premature cessation of menses (MENSTRUATION) when the last menstrual period occurs in a woman under the age of 40. It is due to the depletion of OVARIAN FOLLICLES. Premature MENOPAUSE can be caused by diseases; OVARIECTOMY; RADIATION; chemicals; and chromosomal abnormalities.

A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.

More From BioPortfolio on "Impact of Hot Flashes on Sleep and Mood Disturbance"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial