Comparing Changes in Objective Measures of Sleep Quality During the Menstrual Cycle in Healthy Women: Association With Ovarian Hormones and Mood
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sleep duration
研究概览
简要总结
This study aims to examine how ovarian hormone fluctuations across the menstrual cycle affect sleep patterns. Using objective sleep tracking, hormone phase assessment, and validated questionnaires, it will assess changes in sleep quality, duration, menstrual symptoms, sleepiness, chronotype, anxiety, and depression over one full cycle.
详细描述
Study design:
A prospective community-based study focusing on women of reproductive age (18-36 years) designed to evaluate whether the phase of the menstrual cycle affects sleep quality and/or sleep duration. The study methods and results will be reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) for cross-sectional studies.
Recruitment of Participants:
If approved by the local research ethics committee (VSN-2411037), the study will be registered at ClinicalTrials.gov and women of reproductive age (18-36 years) will be recruited. The main method of recruitment will be a message sent through social media messaging system. Women residing in Iceland will be invited to participate. All the women participating in the study will be provided with information about the study and asked to sign a written informed consent before entering the study. All participants will be allowed to withdraw from the study at any time. Participants will not be financially compensated for their participation.
General Health & Sleep Evaluation (subjective):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, 18-36 years
- •Body Mass Index (BMI) <=35
- •Regular menstrual cycle, defined as: length of menstrual cycle 22-35 days and length of menses <10 days.
- •Women with natural menstrual cycle (i.e., do not use any type of hormonal contraceptives) and women using contraceptives (comparison group).
排除标准
- •Previously diagnosed with:
- •Sleep apnea, clinical insomnia, restless leg syndrome, narcolepsy.
- •Shift work and trans-meridian travel during the study period.
- •Chronic atrial fibrillation or ventricular trigemini, severe uncontrolled asthma, or other pulmonary diseases.
- •Premenstrual Dysphoric Disorder (PMDD) or severe Premenstrual Syndrome (PMS).
- •Other severe medical conditions that may affect cerebral metabolism, cancer, diabetes, rheumatoid arthritis, or other chronic health conditions.
- •Severe psychiatric conditions, Major Depressive disorder, Generalized Anxiety Disorder, Bipolar Disorder, Personality Disorder, OCD, Schizophrenia.
- •Severe neurological conditions, epilepsy, traumatic brain injury, and previous neurosurgery.
- •Habitual smokers and other habitual substance abuse or dependence on substances.
结局指标
主要结局
Sleep duration
时间窗: From March 15 2025 to January 15 2026
1. Sleep duration - calculated in hours. minutes. Sleep output is measured utilizing home sleep test (SleepImage) that is FDA cleared and EU Medical Device Regulation (CE marked) compliant sleep test calculating: Sleep Duration (SD) based on calculating the time from sleep onset (SO) to sleep conclusion (SC) in hours and minutes.
Sleep quality
时间窗: From March 15 2025 to January 15 2026
2. Sleep Quality - based on sleep quality index (SQI) on a scale of 0-100. Sleep output is measured utilizing home sleep test (SleepImage) that is FDA cleared and EU Medical Device Regulation (CE marked) compliant sleep test calculating: Sleep Quality Index (SQI) is summary index of all sleep parameters presented on a scale of 0-100.
次要结局
- Ovulation days(From March 15 2025 to January 15 2026)