Investigation of Sleep and Health Outcomes in Women Reporting Heavy Menses Flow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Women with reported heavy menses
干预措施: Nighttime Feminine Product (Other)
结局指标
主要结局
Change in Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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).
次要结局
未报告次要终点
研究者
Jessica Walter
Principal Investigator
Northwestern University