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Metabolomics of Obstructive Sleep Apnea | Clinical Trials | Clareo Health

COMPLETED

Metabolomics of Obstructive Sleep Apnea

NCT04572269•University of Pennsylvania

Summary

This is an R01 funded project that focuses on the utility of metabolomics as a biomarker for OSA. Aims 1 and 3 leverages banked samples previously collected from subjects with and without OSA at the University of Pennsylvania and University of Iceland. Aim 2 is a prospective study that will collect serum samples from OSA subjects at the University of Pennsylvania and the University of Iceland.

Detailed Description

The primary objective of Aim 2 is to conduct a prospective observational study to evaluate the metabolomic changes in response to six months of positive airway pressure (PAP) treatment among OSA patients. Newly diagnosed OSA patients (AHI\>5) will undergo additional measurements including: accelerometer x one week (to inform the metabolomics), Type 2 home sleep test (to assist with OSA subtyping), next morning blood draw, 24-hour diet recall (to inform the metabolomics), questionnaires and PVT.

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated informed consent form
•2. Stated willingness to comply with all study procedures and availability for the duration of the study
•3. Male or female, aged 30-75 years old
•4. In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI\>5)
•5. Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment.
•6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Exclusion Criteria

•1. Current use of PAP treatment or mandibular advancement device or INSPIRE device
•2. Presence of active cancer treatment or heart failure (ejection fraction \<40%)
•3. Pregnancy or lactation
•4. Known allergic reactions to components of the plastic (used in PAP mask)
•5. Febrile illness within 2 weeks of signing consent
•6. Current drug or alcohol abuse
•7. Known diagnosis and treatment of diabetes because this will independently alter metabolomic results.
•8. Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).

Locations (2)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Iceland

Reykjavik, Iceland

Key Dates

Start Date

September 29, 2020

Primary Completion Date

September 12, 2025

Completion Date

September 12, 2025

Last Updated

October 30, 2025

Enrollment

388

ACTUAL participants

Conditions

Obstructive Sleep Apnea

Interventions

No Intervention

OTHER

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Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metabolomics of Obstructive Sleep Apnea

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea

Diaphragm Ultrasound İn Children With OSAS

BodySleep Algorithm for OSA Diagnosis in Children