Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189755
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-12-06
Brief Title:
MicroRNAs as Biomarkers for Obstructive Sleep Apnea
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
MicroRNAs as Biomarkers for Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIR-OSA
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P01HL160471-01A1 | NIH | None | httpsreporternihgovquickSearch1P01HL160471-01A1 |