Sleep and Health Outcomes in Women With Heavy Menses (NCT05722444) | Clinical Trial Compass
CompletedNot Applicable
Sleep and Health Outcomes in Women With Heavy Menses
United States25 participantsStarted 2023-02-06
Plain-language summary
This study will evaluate subjective sleep over three consecutive menstrual cycles (menses and non-menses) in females reporting heavy menstrual bleeding. Following a baseline phase of one menstrual cycle, study subjects will use a standardized nighttime feminine product during menstruation for their second cycle. For the third cycle, subjects will continue to use the standardized menstrual product with behavioral modification that includes refraining from those sleep behaviors used to avoid nighttime menstrual leakage.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged 18-50 years old
* Generally healthy (self-assessed; no significant underlying disease)
* Premenopausal patients with regular menstrual cycles every 21 to 35 days
* Patients with at least 3 days and no more than 7 days of bleeding during menstruation
* An intact uterus and at least one ovary
* Ability and willingness to provide written informed consent
* Willingness to adhere to study procedures
* Menstrual pads are the primary form for nighttime menstrual protection needs
* Will maintain a daily schedule that allows normal or typical sleep habits (ie, not a night-shift worker; \>5 hours of sleep).
* Women will self-report that they have heavy flow and perform at least one of the following compensatory behaviors:
* Set an alarm or plan to get up in the middle of the night to check or change the pad
* Add additional disposable absorbent products for extra leak protection of coverage (e.g. extra pads or liners)
* Use pillows or other means to limit sleep positions (to prevent moving at night)
* Use something extra on top of my bedding (such as a towel) to sleep on
* Wear an extra pair of pants/shorts
* Wear tighter clothing than they typically would, like yoga pants
Exclusion Criteria:
* Currently pregnant or intending to imminently attempt pregnancy
* Any condition (social or medical) that, in the opinion of the primary care giver or study staff, would make trial participation unsafe or complicate data interpretation
* Difficult …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.