Recruiting

MicroRNAs

Sponsor:

University of Pennsylvania

Code:

NCT06189755

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Positive Airway Pressure

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT06189755

Start date

Apr 1, 2024

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cases

Moderate-severe OSA (defined as AHI ≥15 events/hour)

Controls

No OSA (defined as AHI <5 events/hour)

Interventions

Positive Airway Pressure

Case participants will use Positive Airway Pressure (PAP) treatment as part of routine clinical care.

Primary outcome measure

  • microRNA [ Time Frame: Once at baseline, and after 6 months of PAP treatment, if applicable ]

Central Contacts and Locations

Central contacts

Colleen M Walsh, MS

215-614-0047walshco@pennmedicine.upenn.edu

Kristie C Nguyen

215-615-4112kristie.nguyen@pennmedicine.upenn.edu

Locations

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

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Ulysses J Magalang, MD

614-292-4307ulysses.magalang@osumc.edu

Principal Investigator:

Ulysses J Magalang, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Colleen M Walsh, MS

215-614-0047walshco@pennmedicine.upenn.edu

Allan I Pack, MBChB, PhD

215-746-4806pack@pennmedicine.upenn.edu

Principal Investigator:

Allan I Pack, MBChB, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Sleep Apnea
  • Biomarkers
  • Blood pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-03.