NCT06189755 · University of Pennsylvania
MicroRNAs as Biomarkers for Obstructive Sleep Apnea
(MIR-OSA)
What this study is about
Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients.
View original scientific description
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.
Interventions
DEVICE
Positive Airway Pressure
Case participants will use Positive Airway Pressure (PAP) treatment as part of routine clinical care.
Primary outcome measures
microRNA
Time frame: Once at baseline, and after 6 months of PAP treatment, if applicable
Changes in circulating microRNA profile
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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)
- 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
- 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
Where
- Columbus, Ohio
- Philadelphia, Pennsylvania
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations