Sleep and Health Outcomes in Women With Heavy Menses

Last updated: March 25, 2024
Sponsor: Northwestern University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heavy Bleeding / Heavy Periods

Female Hormonal Deficiencies/abnormalities

Dysfunctional Uterine Bleeding

Treatment

Nighttime Feminine Product

Clinical Study ID

NCT05722444
STU00215465
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 anight-shift worker; >5 hours of sleep).
  • Women will self-report that they have heavy flow and perform at least one of thefollowing compensatory behaviors:
  • Set an alarm or plan to get up in the middle of the night to check or change thepad
  • Add additional disposable absorbent products for extra leak protection ofcoverage (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

Exclusion Criteria:

  • Currently pregnant or intending to imminently attempt pregnancy
  • Any condition (social or medical) that, in the opinion of the primary care giver orstudy staff, would make trial participation unsafe or complicate data interpretation
  • Difficult sleeping environment due to:
  • Frequently involved in activities requiring nighttime awakenings (eg, taking careof 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, includingover the counter products like melatonin.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Nighttime Feminine Product
Phase:
Study Start date:
February 06, 2023
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Department of Dermatology, Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

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