Status:

RECRUITING

MicroRNAs as Biomarkers for Obstructive Sleep Apnea

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Obstructive Sleep Apnea

Eligibility:

All Genders

18-75 years

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 an...

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 iden...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 30 2028

    Estimated Enrollment :

    500 Patients enrolled

    Trial Details

    Trial ID

    NCT06189755

    Start Date

    April 1 2024

    End Date

    April 30 2028

    Last Update

    July 18 2025

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600

    Columbus, Ohio, United States, 43221

    2

    University of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104

    3

    University of Iceland

    Reykjavik, Iceland