MicroRNAs as Biomarkers for Obstructive Sleep Apnea

NCT ID: NCT06189755

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2028-04-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

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

Positive Airway Pressure

Intervention Type: DEVICE

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

Controls

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

No interventions assigned to this group

Interventions

Positive Airway Pressure

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age 18-75 years
• moderate-severe OSA (defined as AHI ≥15 events/hour)
• willing to accept PAP therapy

• 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)
• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan I Pack, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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

Columbus, Ohio, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

University of Iceland

Reykjavik, , Iceland

Site Status: RECRUITING

Countries

United States; Iceland

Central Contacts

Colleen M Walsh, MS

Role: CONTACT

walshco@pennmedicine.upenn.edu

215-614-0047

Kristie C Nguyen

Role: CONTACT

kristie.nguyen@pennmedicine.upenn.edu

215-615-4112

Facility Contacts

Ulysses J Magalang, MD

Role: primary

ulysses.magalang@osumc.edu

614-292-4307

Colleen M Walsh, MS

Role: primary

walshco@pennmedicine.upenn.edu

215-614-0047

Allan I Pack, MBChB, PhD

Role: backup

pack@pennmedicine.upenn.edu

215-746-4806

Thorarinn Gislason, MD

Role: primary

thorarig@landspitali.is

Other Identifiers

1P01HL160471-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

854567

Identifier Type: -

Identifier Source: org_study_id