The research question
How do reported vasomotor symptoms relate to sleep and daytime functioning during routine care?
Proposed design
Prospective patient diary with periodic quality-of-life measures and an optional separately validated wearable sleep module.
Illustrative design: 8- to 12-week follow-up; setup and recruitment are scoped separately.
Data to collect
- Hot-flash and night-sweat frequency and bother
- Reported sleep duration and awakenings
- Daytime fatigue and work interference
- Treatment context and changes
Planned outputs
- Symptom and sleep trajectories
- Patient-reported daily burden
- Diary and wearable agreement where available
What we confirm with you
We agree the population, sample size, country, collection tools, analysis plan and budget. Collection starts after the required consent, ethics or other permissions and a signed scope are in place.
- Define menopause stage and treatment groups
- Separate reported sleep from device-derived estimates
- Use an appropriate design before making treatment comparisons
Clinical records, laboratory results, photographs and device integrations are included only when access, collection quality and permitted use have been verified. Self-reported findings are identified as such.
Research context
These published sources explain the research need or method. They are not RIDLY customers, endorsements or purchase commitments.
- Astellas OPTION-VMS update, October 2026
Astellas reported prospective patient experience and wearable sleep measures in a real-world menopause study.
Related dataset profiles
For an existing-data inquiry, start with a coverage review.