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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with reported heavy menses | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nighttime Feminine Product | Other | During nights while menstruating:
|
| 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 |
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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:
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:
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.
Participants who are born female/undergoing menstruation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |