Menopausal Sleep Fragmentation and Body Fat Gain (NCT03047330) | Clinical Trial Compass
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 range18 Years – 45 Years
SexFEMALE
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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