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Sleep and Health Outcomes in Women With Heavy Menses

Primary Purpose

Menstruation; Heavy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nighttime Feminine Product
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Menstruation; Heavy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Dermatology, Northwestern University Feinberg School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women with reported heavy menses

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
March 2, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05722444
Brief Title
Sleep and Health Outcomes in Women With Heavy Menses
Official Title
Investigation of Sleep and Health Outcomes in Women Reporting Heavy Menses Flow
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstruation; Heavy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with reported heavy menses
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Nighttime Feminine Product
Intervention Description
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 Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
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).
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants who are born female/undergoing menstruation.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dermatology CTU
Phone
312-503-5944
Email
SleepSensors@northwestern.edu
Facility Information:
Facility Name
Department of Dermatology, Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermatology Clinical Trials Unit
Phone
312-503-5944
Email
SleepSensors@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Jessica Walter, MD

12. IPD Sharing Statement

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Sleep and Health Outcomes in Women With Heavy Menses

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