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Completed

NCT Number: NCT05722444

Sleep and Health Outcomes in Women With Heavy Menses

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nighttime Feminine Product

Other

During nights while menstruating:

  • Standardized nighttime feminine product + typical nighttime behaviors to prevent leak
  • Standardized nighttime feminine product + refraining from nighttime behaviors to prevent leak

Primary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 3 months

    Determine the change in PSQI over the 3 months of study participation. Maximum score is 21 (worse sleep outcomes) and minimum score is 0 (better sleep outcomes).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Investigation of Sleep and Health Outcomes in Women Reporting Heavy Menses Flow

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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