NCT06189755

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Apr 2024Apr 2028

First Submitted

Initial submission to the registry

December 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

December 6, 2023

Last Update Submit

July 15, 2025

Conditions

Obstructive Sleep Apnea

Keywords

Sleep ApneaBiomarkersBlood pressure

Outcome Measures

Primary Outcomes (1)

  • microRNA

    Changes in circulating microRNA profile

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

Secondary Outcomes (1)

  • 24-hour mean blood pressure (24hMBP)

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

Study Arms (2)

Cases

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

Device: Positive Airway Pressure

Controls

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

Interventions

Positive Airway PressureDEVICE

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

Cases

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Columbus, Ohio, 43221, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Iceland

Reykjavik, Iceland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

As part of the research protocol, a sample of blood (30 mL total) will be drawn at baseline. Repeat blood draw (30 mL) will be done in the 250 subjects after 6 months of PAP therapy. The blood samples will be used to measure microRNAs, other blood biomarkers such as DNA buffy coat, serum for metabolomics, and serum creatinine in those who have no values in their medical records within the 12 months. The investigators will perform DNA genotyping to look for genetic variants that correlate with obstructive sleep apnea.

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Allan I Pack, MBChB, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen M Walsh, MS

CONTACT

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

Kristie C Nguyen

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

January 5, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations

IC(1)US(2)