Sleep and Health Outcomes in Women With Heavy Menses

Northwestern University

Status

Active, not recruiting

Conditions

Menstruation; Heavy

Treatments

Other: Nighttime Feminine Product

Study type

Interventional

Funder types

Other

Identifiers

NCT05722444

STU00215465

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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 sleeping environment due to:
- Frequently involved in activities requiring nighttime awakenings (eg, taking care of an infant or loved one).
- Disruptive bed partners (i.e., snoring, children, pets, etc)
- Diagnosed sleep disorders (i.e. insomnia, sleep apnea, restless leg disorder, breathing disorder, etc)
Use of an Intrauterine Device (IUDs) unless copper IUD.
Regular use (>1 day per week) of sleep aids and/or sedating medications, including over the counter products like melatonin.