CompletedPhase 4

Menopausal Sleep Fragmentation and Body Fat Gain

United States41 participantsStarted 2017-07-15

Plain-language summary

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 fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy premenopausal women 18-45 years old * Regular sleep schedule * Limited alcohol and caffeine intake * Regular monthly menstrual cycles * No lifetime history of hot flashes * Willingness to use approved methods of contraception during study * Not obese * Good general health Exclusion Criteria: * Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists * Pregnancy * Breastfeeding * Tobacco use * Contraindicated systemic hormone medications or centrally active medications * Shift workers or recent/expected time zone travel * Obstructive sleep apnea * Insomnia symptoms * Diagnosis of osteoporosis or osteopenia * Hypothalamic-pituitary-adrenal axis disorders * Diabetes * Gastric bypass, metabolic disorders, or other related conditions * Abnormalities on screening laboratory tests * Substantial hearing impairment * Cardiovascular illness * Neurological illness * Recent psychiatric illness or substance-use disorder

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Normalized Serum Leptin Levels

Timeframe: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

Trial details

NCT IDNCT03047330

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-01

Results submitted2024-02-09

View on ClinicalTrials.gov More Menopause trials