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ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized, parallel-group study will examine how artificial light exposure during nighttime awakenings affects sleep and brain health in midlife women experiencing vasomotor symptoms, such as hot flashes and night sweats. Participants will be randomly assigned to exposure to either typical indoor-intensity light (approximately 100 lux) or dim light (less than 3 lux) during the night. The study will assess the effects of nighttime light exposure on sleep fragmentation, daytime alertness and sleepiness, stress responses, cognitive and emotional functioning, and daily functioning. It will also explore whether sleep fragmentation helps explain the effects of nighttime light exposure on stress and neuropsychological health. The findings may inform strategies to reduce nighttime light exposure and improve sleep and brain health in women during and after the menopause transition.
Trial Details
NCT Number NCT07834944
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: National Institute on Aging (NIA)
Conditions Women in the Menopausal Period
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov