Sleep Apnea in Non-ovulating REI Patients: The SNORES Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- Ovulatory cycles
研究概览
简要总结
Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.
详细描述
The investigators' goal is to perform a randomized clinical trial among women with PCOS who present for infertility treatment. Our primary outcome is to determine if screening women with PCOS, and treating those with confirmed sleep apnea, will lead to more ovulatory cycles. Our sub-aims are to describe the rate of OSA and sleep symptoms in patients with PCOS, to see if current sleep questionnaires correlate to a diagnostic sleep study, to describe the correlation between OSA and biomarkers of glucose homeostasis in women with PCOS, to investigate health related quality of life between the groups, to compare perinatal outcomes between the groups, and to evaluate the composition of breastmilk among women who choose to breastfeed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 18 - 50 years old.
- •Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinology infertility specialist
- •Polycystic ovarian syndrome defined by the modified Rotterdam criteria
- •Able to speak and understand as well as give informed consent in English
排除标准
- •Late onset congenital adrenal hyperplasia
- •Cushings disease
- •Androgen-secreting tumors
- •Previous diagnosis of obstructive sleep apnea
- •Current use of over the counter or prescribed sleep medications.
- •Examples of medications that exclude a patient from this study include but are not limited to Unisom, Ambien or Lunesta.
- •Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these include but are not limited to melatonin, chamomile, or valerian.
- •Untreated thyroid disease
- •Prolactin excess
- •Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure.
研究组 & 干预措施
Usual care
Screen for Sleep Apnea
Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea
干预措施: Screening for obstructive sleep apnea (Other)
Screen for Sleep Apnea
Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea
干预措施: CPAP - continuous positive airway pressure (Device)
结局指标
主要结局
Ovulatory cycles
时间窗: 3 months
次要结局
未报告次要终点