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Recruiting NCT06189755

NCT06189755 MicroRNAs as Biomarkers for Obstructive Sleep Apnea

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Clinical Trial Summary
NCT ID NCT06189755
Status Recruiting
Phase
Sponsor University of Pennsylvania
Condition Obstructive Sleep Apnea
Study Type OBSERVATIONAL
Enrollment 500 participants
Start Date 2024-04-01
Primary Completion 2027-11-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 75 Years
Study Type OBSERVATIONAL
Interventions
Positive Airway Pressure

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 500 participants in total. It began in 2024-04-01 with a primary completion date of 2027-11-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Colleen M Walsh, MS

✉ walshco@pennmedicine.upenn.edu

📞 215-614-0047

Principal Investigator

Allan I Pack, MBChB, PhD

PRINCIPAL INVESTIGATOR

University of Pennsylvania

Frequently Asked Questions

Who can join the NCT06189755 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06189755 currently recruiting?

Yes, NCT06189755 is actively recruiting participants. Contact the research team at walshco@pennmedicine.upenn.edu for enrollment information.

Where is the NCT06189755 trial being conducted?

This trial is being conducted at Columbus, United States, Philadelphia, United States, Reykjavik, Iceland.

Who is sponsoring the NCT06189755 clinical trial?

NCT06189755 is sponsored by University of Pennsylvania. The principal investigator is Allan I Pack, MBChB, PhD at University of Pennsylvania. The trial plans to enroll 500 participants.

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