MicroRNAs as Biomarkers for Obstructive Sleep Apnea

ConditionObstructive Sleep Apnea

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-75 years

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

willing to accept PAP therapy

age 18-75 years

Disqualifiers

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

Trial population

Participants who had a clinical sleep study who meet inclusion criteria for age and AHI and none of the exclusion criteria will be identified using the sleep center databases and electronic medical records. The investigators will also recruit participants from the community- these participants will undergo home sleep study with EEG. The investigators will make a conscious effort to recruit from all ethnic and social economic backgrounds.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: Cases1 intervention

Group B: Controls0 interventions

Trial outcomes

Primary outcomes

microRNA

Changes in circulating microRNA profile

Time frame

Once at baseline, and after 6 months of PAP treatment, if applicable

Secondary outcomes

24-hour mean blood pressure (24hMBP)

Ambulatory blood pressure monitoring of systolic and diastolic blood pressure

Time frame

Measured for 24-hours at baseline, and repeated after 6 months of PAP treatment, if applicable

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)