Sleep and Health Outcomes in Women With Heavy Menses

Not Applicable

Active, not recruiting

• Conditions: Menstruation; Heavy
• Interventions: Other: Nighttime Feminine Product

• Registration Number: NCT05722444
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study Start: 2023-02-06
• Study First Posted: 2023-02-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with reported heavy menses	Nighttime Feminine Product	-

Primary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	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).

Trial Locations

Locations (1)

Department of Dermatology, Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States