NCT04572269

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
388

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 25, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

September 25, 2020

Last Update Submit

April 21, 2026

Conditions

Obstructive Sleep Apnea

Keywords

MetabolomicsBiomarkerPAPOSA SubtypePersonalized medicine

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (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 anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.

Other Outcomes (2)

  • Evaluate whether the metabolomic response to PAP treatment is modified by degree of obesity.

    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.

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

Study Arms (1)

Subjects with OSA

Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI \>5)

Other: No Intervention

Interventions

No InterventionOTHER

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

Subjects with OSA

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Iceland

Reykjavik, 108, Iceland

Location

Related Publications (13)

  • 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.

    PMID: 23589584BACKGROUND

  • 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.

    PMID: 27732789BACKGROUND

  • 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.

    PMID: 19515590BACKGROUND

  • 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.

    PMID: 16424443BACKGROUND

  • 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.

    PMID: 24452224BACKGROUND

  • 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.

    PMID: 16282178BACKGROUND

  • 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.

    PMID: 19797158BACKGROUND

  • 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.

    PMID: 8464434BACKGROUND

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

    PMID: 12840659BACKGROUND

  • 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.

    PMID: 1203753BACKGROUND

  • 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.

    PMID: 29522222BACKGROUND

  • 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.

    PMID: 16808451BACKGROUND

  • 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.

    PMID: 27472375BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Platelet Poor Plasma (PPP), Peripheral Blood Monocyte Cell (PBMC) and anticoagulated whole blood,

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Allan Pack, MBChB, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Aalim Weljie, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 1, 2020

Study Start

September 29, 2020

Primary Completion

September 12, 2025

Study Completion

September 12, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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\>.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
IPD will be available to research teams within 1 year following study completion.
Access Criteria
Data collected for this study will be analyzed and stored in figshare \<https://figshare.com\>. After the study is completed, the de-identified, archived data will be transmitted to and stored in figshare \<https://figshare.com\>, for use by other researchers including those outside of the study.
More information

Locations

IC(1)US(1)