Research During the Menopause Transition

Brain Health and Hot Flashes in Postmenopausal Women

Completed Accrual

  • This study will 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 project is part of the Brigham/Harvard Reproductive Outcomes of Stress and Aging (ROSA) Center in the BWH Connors Center for Women’s Health Research.

Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women 

Completed Accrual

  • This NIH-funded clinical research study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. We hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

Efficacy of Suvorexant in the Treatment of Hot Flash-Associated Insomnia 

Completed Accrual

  • The aim of this study is to determine the effect of suvorexant, an FDA-approved medication, on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.

    Participants completed 4 visits and were randomized to receive either study drug or a placebo. Participants took a daily pill for 4 weeks to complete the trial.

    Related publications:

    Manuscript in progress

Psychological and Automatic Hyperarousal in Menopausal Hot Flash-Associated Insomnia

Completed Accrual

  • This is a cross-sectional study comparing the psychological and physiologic profiles of hyperarousal among perimenopausal and postmenopausal women with vs. without insomnia.

    Related publications:

    Bertisch, SM et al. Cardiovascular reactivity and psychological hyperarousal in hot flash-associated insomnia disorder. Menopause 2019 Jan 21.

    https://www.ncbi.nlm.nih.gov/pubmed/30672883

Stress Response in Midlife Women with Hot Flashes 

Completed Accrual

  • This study aims to characterize stress response in both peri- and postmenopausal women who either are or are not suffering from hot flashes. We also aim to determine which measures of anxiety best correlate with hot flashes in these women.

    Related Publications:

    Nathan MD, Wiley A, Mahon PB, Camuso J, Sullivan K, McCormick K, Srivastava A, Albert K, Newhouse P, Joffe H. Hypothalamic-pituitary-adrenal axis, subjective, and thermal stress responses in midlife women with vasomotor symptoms. Menopause. 2020 Dec 14;28(4):439-443. doi: 10.1097/GME.0000000000001703. PMID: 33323762.

    https://pubmed.ncbi.nlm.nih.gov/33323762/

Effects of Estradiol and Hot Flashes on Mood in Permenopausal Women 

Completed Accrual

  • This observational study looks at changes in estradiol levels and depression symptoms in perimenopausal and premenopausal women. The aim is to determine whether hot flashes are an important intermediary in the generation of perimenopause-associated depression.

    Related Publications:

    Joffe H, de Wit A, Coborn J, Crawford S, Freeman M, Wiley A, Athappilly G, Kim S, Sullivan KA, Cohen LS, Hall JE. Impact of Estradiol Variability and Progesterone on Mood in Perimenopausal Women With Depressive Symptoms. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e642–50. doi: 10.1210/clinem/dgz181. PMID: 31693131; PMCID: PMC7075107.

    https://pubmed.ncbi.nlm.nih.gov/31693131/

    de Wit AE, Giltay EJ, de Boer MK, Nathan M, Wiley A, Crawford S, Joffe H. Predictors of irritability symptoms in mildly depressed perimenopausal women. Psychoneuroendocrinology. 2021 Apr; 126:105128. doi: 10.1016/j.psyneuen.2021.105128. Epub 2021 Jan 7. PMID: 33493755.

    https://pubmed.ncbi.nlm.nih.gov/33493755/