Metabolomics of Obstructive Sleep Apnea (MOSA)

May 11, 2026 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavik, Iceland, 108
        • University of Iceland
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Prospective recruitment of female and male OSA subjects n=500/site: Site #1 is University of Pennsylvania; Site #2 is University of Iceland for a total of n=1000 cases.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with OSA
Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI >5)
Other: No Intervention
This protocol does not involve an intervention of drug/device, diet, exercise or PAP compliance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment.
Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.
New OSA patients, AHI>5 will be recruited. Since this is a real-world trial, compliance of PAP usage will vary from 0 to 100%. Thus, we will be able to assess not only what metabolomic changes occur with PAP usage but also whether there is a correlation to the amount of PAP usage. Metabolomics can be used as a biomarker that correlates with duration and frequency of PAP usage. This will then be correlated to subjective and objective measures of daytime sleepiness (questionnaires + PVT) and sleep fragmentation.
We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine a metabolic signature that correlates with duration and frequency of PAP usage. This will then be correlated to subjective and objective measures of daytime sleepiness and sleep fragmentation.
Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.
We will assess whether there is a specific metabolic signature that strongly associates with PAP adherence, potentially independent of the metabolites in Outcome 1. Identifying the set of metabolites with the strongest association with PAP usage will allow us to define an objective biomarker for quantifying PAP adherence. Moreover, the pathways implicated by these biomarkers are likely to allude to certain mechanisms of response.
We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate whether the metabolomic response to PAP treatment is modified by degree of obesity.
Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.
We will utilize conditional MSMs that estimate whether the effect of PAP varies with BMI.
We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.
Examine whether OSA symptom subtypes have a different metabolomic responses to PAP treatment.
Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.
We will utilize conditional MSMs that estimate whether the effect of PAP varies across symptom subtypes.
We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

University of Iceland

Investigators

  • Principal Investigator: Aalim Weljie, PhD, University of Pennsylvania
  • Principal Investigator: Allan Pack, MBChB, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Actual)

September 12, 2025

Study Completion (Actual)

September 12, 2025

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 835027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored in REDcap. This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and by the University of Pennsylvania research staff will be secured and password protected. At the end of the study, all study databases will be de-identified and archived at figshare .

IPD Sharing Time Frame

IPD will be available to research teams within 1 year following study completion.

IPD Sharing Access Criteria

Data collected for this study will be analyzed and stored in figshare . After the study is completed, the de-identified, archived data will be transmitted to and stored in figshare , for use by other researchers including those outside of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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