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临床试验/NCT06189755
NCT06189755招募中不适用

MicroRNAs as Biomarkers for Obstructive Sleep Apnea

University of Pennsylvania4 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
4
主要终点
microRNA

研究概览

简要总结

Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients. This project will study microRNAs in order to develop and validate blood biomarkers that are specific to OSA, useful for identification of cases with OSA, reflective of efficacy of therapy, and able to predict blood pressure response to treatment of OSA.

详细描述

While obstructive sleep apnea (OSA) is common, there are limited biomarkers for identification and management of the condition. Specific use cases for an OSA biomarker include: (i) improving case identification, (ii) monitoring efficacy of therapy, and (iii) providing prognostic value with respect to who will get particular consequences or how individuals respond to continuous positive airway pressure (CPAP) treatment. While different approaches can be used to define biomarkers, this project will focus on microRNAs, which have very recently been shown to be promising biomarkers in OSA. MicroRNAs are small non-coding RNAs that alter the translation of protein coding RNA. Their expression is dynamic and altered by many challenges, such as hypoxia. Expression of all microRNAs in blood can be assessed by sequencing all short RNAs. Prior studies, albeit with small sample sizes, suggest differences in microRNA expression between OSA cases and controls and that differences in microRNA expression can identify individuals with OSA who will show larger blood pressure responses to CPAP treatment. Using complementary sequencing approaches and clinically-feasible quantitative PCR (qPCR), the investigators propose to validate and extend these initial observations. First, the investigators will seek biomarkers that are specific to OSA by evaluating differences in microRNA profiles between cases with OSA and controls without OSA matched for age, sex, and body mass index and without other underlying conditions that could independently affect microRNA expression. While identifying microRNAs specific to OSA is important, it is also useful to determine microRNAs useful for improving OSA case identification beyond known clinical risk factors. Thus, this project will enroll a larger case-control sample with minimal exclusion criteria in which to assess the predictive value of differences in microRNA expression. To understand the utility of microRNAs as treatment-related biomarkers, cases with OSA will be studied before and after 6 months of CPAP. The investigators anticipate that some microRNAs specific to OSA will normalize with CPAP treatment, thus providing an objective measure of effectiveness. In all OSA cases, the investigators will assess 24-hour ambulatory blood pressure to validate and extend recent reports of a microRNA signature that predicts blood pressure response to CPAP. The investigators will conduct robust validation for all biomarkers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-75 years
  • moderate-severe OSA (defined as AHI ≥15 events/hour)
  • willing to accept PAP therapy
  • Inclusion Criteria for Controls:
  • age 18-75 years
  • no OSA (defined as AHI <5 events/hour)

排除标准

  • current use of PAP or other OSA treatments
  • home oxygen therapy
  • recent changes (within 3 months) to BP medications among those who are on these medications
  • presence of Cheyne-Stokes Respiration (CSR) in sleep study
  • predominantly central sleep apnea (AHI≥15 events/hour, with >50% central events)
  • pregnancy
  • clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
  • organ transplantation
  • self-reported sleep duration less than 5 hours per night on weeknights (work nights)
  • current night shift work
  • Exclusion Criteria for Controls:
  • home oxygen therapy
  • pregnancy
  • clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
  • organ transplantation
  • self-reported sleep duration less than 5 hours per night on weeknights (work nights)
  • current night shift work

结局指标

主要结局

microRNA

时间窗: Once at baseline, and after 6 months of PAP treatment, if applicable

Changes in circulating microRNA profile

次要结局

  • 24-hour mean blood pressure (24hMBP)(Measured for 24-hours at baseline, and repeated after 6 months of PAP treatment, if applicable)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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