Sleep and Health Outcomes in Women With Heavy Menses

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Menstruation; Heavy
• Intervention / Treatment: Other: Nighttime Feminine Product

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Department of Dermatology, Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women with reported heavy menses	Other: Nighttime Feminine Product; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)	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).	3 months

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Menorrhagia
• Other Study ID Numbers: STU00215465

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No