Exhaled Nitric Oxide as a Biomarker of Gestational Obstructive Sleep Apnea and Persistence Postpartum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Difference in incidence of Obstructive Sleep Apnea (OSA)
研究概览
简要总结
This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the third trimester of pregnancy and again postpartum.
详细描述
This is a prospective cohort study to evaluate the presence or absence of OSA in the third trimester of pregnancy and again postpartum. The investigators will use the Watch-PAT200® device as their accepted standard for diagnosis of obstructive sleep apnea.
When enrolled, women will be taught how to use the Watch-PAT200® via a company produced video that will be shown in the clinic and will be available via YouTube for review later if needed. They will also complete the Berlin Questionnaire. The patient will then use the Watch-PAT200® device overnight to evaluate for obstructive sleep apnea. This will be performed between 32-36 weeks gestation. Apnea-hypopnea indices (AHI) will be calculated and an AHI>5 will be considered diagnostic for OSA.
The next morning when the patient returns the Watch-PAT200® device they will exhale into the NIOX MINO® to assess their exhaled nitric oxide levels. This will be performed between 800-1000 am by one of the study personnel.
The patient will also wear the Watch-PAT200® device the first postpartum night. The entire process will be repeated between 6-8 weeks postpartum.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female (> or equal 18 year of age)
- •Pregnant between 32 0/7 prior to 35 6/7 weeks gestation
- •Anticipated delivery at Forsyth Medical Center: Winston Salem, North Carolina
排除标准
- •Illicit drug/Alcohol abuse
- •Current treatment for obstructive sleep apnea
- •Age <18 years
- •Inability to speak/read English proficiently enough to give informed consent
- •Usage of alpha blockers or short acting nitrates
- •Permanent pacemaker
- •Sustained non-sinus cardiac arrhythmias
结局指标
主要结局
Difference in incidence of Obstructive Sleep Apnea (OSA)
时间窗: 6-8 weeks postpartum
The difference in incidence of OSA during the third trimester and postpartum. We assumed an incidence of 25% during the third trimester, reducing to 6% postpartum. Comparison will be made with McNemar's test on proportions at an α level of 0.05.
次要结局
未报告次要终点