Brain health and hot flashes in postmenopausal women (ROSA P1)
This study aimed to advance the health of postmenopausal women by determining stress responses, neural processes, and neurobiological mechanisms that are affected when hot flashes occur and persist. This study was a part of the Reproductive Outcomes of Stress and Aging (ROSA) Center, an NIH U54 Specialized Center of Research Excellence on Sex Differences. This study was conducted at Brigham and Women's Hospital.
Funding: NIH U54
Publications: To be updated
Menopause, insomnia, and risk for cardiovascular disease (MINDY)
This study aimed to investigate the efficacy of suvorexant on insomnia symptoms and on metabolic health in midlife women with insomnia, and to learn whether improvement in insomnia symptoms is linked with improvement in metabolic health outcomes. This study was conducted at Brigham and Women's Hospital.
NCT: NCT05593653
Funding: Merck Investigator Studies Program
Publications: in progress
Menopausal sleep fragmentation: Impact on body fat gain biomarkers in women (DAISY)
This study aimed to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. We hypothesized that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain. This study was conducted at Brigham and Women's Hospital.
NCT: NCT03047330
Funding: NIH R01
Publications:
Nathan MD, Spagnolo PA et al. 2026. Impact of sleep fragmentation and estradiol suppression on positive and negative affect: Results of an experimental model of menopause. PMCID: PMC12661796
Grant LK, Gonsalvez I et al. 2024. The effect of experimentally induced sleep fragmentation and estradiol suppression on neurobehavioral performance and subjective sleepiness in premenopausal women. PMCID: PMC11321839
Cohn AY, Grant LK et al. 2023. Effects of sleep fragmentation and estradiol decline on cortisol in a human experimental model of menopause. PMCID: PMC10584010
Grant LK, Coborn JE et al. 2022. Sleep fragmentation and estradiol suppression decrease fat oxidation in premenopausal women. PMCID: PMC9282266
Study of fatigue in patients on palbociclib (SOFI-P)
This observational study of patients with metastatic breast cancer aimed to investigate the development and course of fatigue during the first 6 months of palbociclib combination therapy. We also examined the patient perspective on fatigue and other effects of palbociclib combination therapy on quality of life. This study was conducted at Dana Farber Cancer Institute and Brigham and Women’s Hospital.
Funding: Pfizer Investigator Research Exchange (ASPIRE) Oncology/Hematology Clinical Research Award
Publications:
Rahman SA, Poort H et al. 2025. Incidence of patient-reported fatigue developing on palbociclib and endocrine therapy for advanced HR+ HER2- breast cancer. PMCID: PMC12395256
Efficacy of suvorexant in the treatment of hot flash-associated insomnia (DORA)
The aim of this study was to determine the effect of suvorexant, an FDA-approved medication, on insomnia symptoms in peri- and postmenopausal women who were experiencing sleep difficulties related to nighttime hot flashes. Participants completed 4 visits over 4 weeks and were randomized to receive either study drug or a placebo. This study was conducted at Brigham and Women's Hospital.
NCT: NCT03034018
Funding: Merck Investigator Studies Program
Publications:
1. Rahman SA, Nathan MD et al. 2022. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women - PMID: 35022783