Metabolomics of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 4
- 主要终点
- Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment.
研究概览
简要总结
This is an R01 funded project that focuses on the utility of metabolomics as a biomarker for OSA. Aims 1 and 3 leverages banked samples previously collected from subjects with and without OSA at the University of Pennsylvania and University of Iceland. Aim 2 is a prospective study that will collect serum samples from OSA subjects at the University of Pennsylvania and the University of Iceland.
详细描述
The primary objective of Aim 2 is to conduct a prospective observational study to evaluate the metabolomic changes in response to six months of positive airway pressure (PAP) treatment among OSA patients. Newly diagnosed OSA patients (AHI>5) will undergo additional measurements including: accelerometer x one week (to inform the metabolomics), Type 2 home sleep test (to assist with OSA subtyping), next morning blood draw, 24-hour diet recall (to inform the metabolomics), questionnaires and PVT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 30-75 years old
- •In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI>5)
- •Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment.
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
排除标准
- •Current use of PAP treatment or mandibular advancement device or INSPIRE device
- •Presence of active cancer treatment or heart failure (ejection fraction <40%)
- •Pregnancy or lactation
- •Known allergic reactions to components of the plastic (used in PAP mask)
- •Febrile illness within 2 weeks of signing consent
- •Current drug or alcohol abuse
- •Known diagnosis and treatment of diabetes because this will independently alter metabolomic results.
- •Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).
研究组 & 干预措施
Subjects with OSA
Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI >5)
干预措施: No Intervention (Other)
结局指标
主要结局
Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment.
时间窗: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.
New OSA patients, AHI\>5 will be recruited. Since this is a real-world trial, compliance of PAP usage will vary from 0 to 100%. Thus, we will be able to assess not only what metabolomic changes occur with PAP usage but also whether there is a correlation to the amount of PAP usage. Metabolomics can be used as a biomarker that correlates with duration and frequency of PAP usage. This will then be correlated to subjective and objective measures of daytime sleepiness (questionnaires + PVT) and sleep fragmentation.
次要结局
- Determine a metabolic signature that correlates with duration and frequency of PAP usage. This will then be correlated to subjective and objective measures of daytime sleepiness and sleep fragmentation.(We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.)