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Obstructive Sleep ApneaMOSANCT04572269

Metabolomics of Obstructive Sleep Apnea

An observational study of Obstructive Sleep Apnea, run by University of Pennsylvania at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Obstructive Sleep Apnea
How many people
388 participants
Where
2 sitesin 2 countries
Study dates
29 Sep 2020to 12 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 30-75 years old
  • In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI>5)
  • Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment.
  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Iceland1 site

  • University of Iceland

    Reykjavik, 108

Other trials in Iceland

About this study

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.

Read the 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.

Being tested
No Intervention
Keywords
Metabolomics, Biomarker, PAP, OSA Subtype, Personalized medicine
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    This protocol does not involve an intervention of drug/device, diet, exercise or PAP compliance.

Study groups in NCT04572269
Study groupRoleWhat they receive
Subjects with OSAFemale and male subjects with Obstructive Sleep Apnea (OSA) (AHI >5)
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment.

    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.

    Measured: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.

Secondary outcomes (1)

  1. 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.

    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.

    Measured: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study start29 Sep 2020
  3. Primary completion12 Sep 2025
  4. Study completion12 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04572269
Sponsor's protocol ID
835027
Acronym
MOSA
Status last verified
May 2026
First submitted
25 Sep 2020
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 \<https://figshare.com\>.

Publications

  • Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.

    PubMed 23589584

  • Lim DC, Pack AI. Obstructive Sleep Apnea: Update and Future. Annu Rev Med. 2017 Jan 14;68:99-112. doi: 10.1146/annurev-med-042915-102623. Epub 2016 Oct 5.

    PubMed 27732789

  • Duran-Cantolla J, Aizpuru F, Martinez-Null C, Barbe-Illa F. Obstructive sleep apnea/hypopnea and systemic hypertension. Sleep Med Rev. 2009 Oct;13(5):323-31. doi: 10.1016/j.smrv.2008.11.001. Epub 2009 Jun 9.

    PubMed 19515590

  • Mehra R, Benjamin EJ, Shahar E, Gottlieb DJ, Nawabit R, Kirchner HL, Sahadevan J, Redline S; Sleep Heart Health Study. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006 Apr 15;173(8):910-6. doi: 10.1164/rccm.200509-1442OC. Epub 2006 Jan 19.

    PubMed 16424443

  • Li M, Hou WS, Zhang XW, Tang ZY. Obstructive sleep apnea and risk of stroke: a meta-analysis of prospective studies. Int J Cardiol. 2014 Mar 15;172(2):466-9. doi: 10.1016/j.ijcard.2013.12.230. Epub 2014 Jan 10. No abstract available.

    PubMed 24452224

  • Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.

    PubMed 16282178

  • Gozal D, Jortani S, Snow AB, Kheirandish-Gozal L, Bhattacharjee R, Kim J, Capdevila OS. Two-dimensional differential in-gel electrophoresis proteomic approaches reveal urine candidate biomarkers in pediatric obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1253-61. doi: 10.1164/rccm.200905-0765OC. Epub 2009 Sep 24.

    PubMed 19797158

  • Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.

    PubMed 8464434

  • Schaffer JE. Lipotoxicity: when tissues overeat. Curr Opin Lipidol. 2003 Jun;14(3):281-7. doi: 10.1097/00041433-200306000-00008.

    PubMed 12840659

  • Taylor WM, Halperin ML. Effect of valine on the control of fatty acid synthesis in white adipose tissue of the rat. Can J Biochem. 1975 Oct;53(10):1054-60. doi: 10.1139/o75-145.

    PubMed 1203753

  • Gehrman P, Sengupta A, Harders E, Ubeydullah E, Pack AI, Weljie A. Altered diurnal states in insomnia reflect peripheral hyperarousal and metabolic desynchrony: a preliminary study. Sleep. 2018 May 1;41(5):zsy043. doi: 10.1093/sleep/zsy043.

    PubMed 29522222

  • Weljie AM, Newton J, Mercier P, Carlson E, Slupsky CM. Targeted profiling: quantitative analysis of 1H NMR metabolomics data. Anal Chem. 2006 Jul 1;78(13):4430-42. doi: 10.1021/ac060209g.

    PubMed 16808451

  • Sengupta A, Krishnaiah SY, Rhoades S, Growe J, Slaff B, Venkataraman A, Olarerin-George AO, Van Dang C, Hogenesch JB, Weljie AM. Deciphering the Duality of Clock and Growth Metabolism in a Cell Autonomous System Using NMR Profiling of the Secretome. Metabolites. 2016 Jul 27;6(3):23. doi: 10.3390/metabo6030023.

    PubMed 27472375

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by University of Pennsylvania at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04572269, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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