Identifying blood biomarkers for obstructive sleep apnea using microRNAs
MicroRNAs as Biomarkers for Obstructive Sleep Apnea
This study is testing if certain blood markers can help identify obstructive sleep apnea in people by looking at tiny molecules called microRNAs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 3 sites (Columbus, Ohio and 2 other locations) |
| Trial ID | NCT06189755 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate blood biomarkers specific to obstructive sleep apnea (OSA) by analyzing microRNAs. The research will compare microRNA profiles between individuals with moderate to severe OSA and healthy controls matched for age, sex, and body mass index. The study will utilize sequencing techniques and quantitative PCR to assess microRNA expression, which may help improve case identification, monitor therapy efficacy, and predict blood pressure responses to treatment. By establishing these biomarkers, the study seeks to enhance the management of OSA patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with moderate to severe obstructive sleep apnea who are willing to accept positive airway pressure therapy.
Not a fit: Patients currently using positive airway pressure therapy or with certain medical conditions, such as chronic kidney disease requiring dialysis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of obstructive sleep apnea through the use of specific blood biomarkers.
How similar studies have performed: Previous studies have suggested differences in microRNA expression between OSA cases and controls, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Cases: * 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 for Cases: * 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
Where this trial is running
Columbus, Ohio and 2 other locations
- The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600 — Columbus, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Iceland — Reykjavik, Iceland (Recruiting)
Study contacts
- Principal investigator: Allan I Pack, MBChB, PhD — University of Pennsylvania
- Study coordinator: Colleen M Walsh, MS
- Email: walshco@pennmedicine.upenn.edu
- Phone: 215-614-0047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.