Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-02 @ 1:06 AM
Study NCT ID:
NCT04572269
Status:
COMPLETED
Last Update Posted:
2025-10-30
First Post:
2020-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomics of Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, Plasma, Platelet Poor Plasma (PPP), Peripheral Blood Monocyte Cell (PBMC) and anticoagulated whole blood,'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate whether the metabolomic response to PAP treatment is modified by degree of obesity.', 'timeFrame': 'We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.', 'description': 'We will utilize conditional MSMs that estimate whether the effect of PAP varies with BMI.'}, {'measure': 'Examine whether OSA symptom subtypes have a different metabolomic responses to PAP treatment.', 'timeFrame': 'We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.', 'description': 'We will utilize conditional MSMs that estimate whether the effect of PAP varies across symptom subtypes.'}], 'primaryOutcomes': [{'measure': 'Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment.', 'timeFrame': 'We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolomics', 'Biomarker', 'PAP', 'OSA Subtype', 'Personalized medicine'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '23589584', 'type': 'BACKGROUND', 'citation': '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': '27732789', 'type': 'BACKGROUND', 'citation': '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': '19515590', 'type': 'BACKGROUND', 'citation': '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': '16424443', 'type': 'BACKGROUND', 'citation': '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': '24452224', 'type': 'BACKGROUND', 'citation': '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': '16282178', 'type': 'BACKGROUND', 'citation': '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': '19797158', 'type': 'BACKGROUND', 'citation': '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': '8464434', 'type': 'BACKGROUND', 'citation': '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': '12840659', 'type': 'BACKGROUND', 'citation': 'Schaffer JE. Lipotoxicity: when tissues overeat. Curr Opin Lipidol. 2003 Jun;14(3):281-7. doi: 10.1097/00041433-200306000-00008.'}, {'pmid': '1203753', 'type': 'BACKGROUND', 'citation': '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': '29522222', 'type': 'BACKGROUND', 'citation': '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': '16808451', 'type': 'BACKGROUND', 'citation': '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': '27472375', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 30-75 years old\n4. In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI\\>5)\n5. Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment.\n6. 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.\n\nExclusion Criteria:\n\n1. Current use of PAP treatment or mandibular advancement device or INSPIRE device\n2. Presence of active cancer treatment or heart failure (ejection fraction \\<40%)\n3. Pregnancy or lactation\n4. Known allergic reactions to components of the plastic (used in PAP mask)\n5. Febrile illness within 2 weeks of signing consent\n6. Current drug or alcohol abuse\n7. Known diagnosis and treatment of diabetes because this will independently alter metabolomic results.\n8. Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).'}, 'identificationModule': {'nctId': 'NCT04572269', 'acronym': 'MOSA', 'briefTitle': 'Metabolomics of Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Metabolomics of Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '835027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with OSA', 'description': 'Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI \\>5)', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This protocol does not involve an intervention of drug/device, diet, exercise or PAP compliance.', 'armGroupLabels': ['Subjects with OSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '108', 'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'University of Iceland', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}], 'overallOfficials': [{'name': 'Allan Pack, MBChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Aalim Weljie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'url': 'http://figshare.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be available to research teams within 1 year following study completion.', 'ipdSharing': 'YES', '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 \\<https://figshare.com\\>.", 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Iceland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}