Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-30 @ 3:59 AM
Study NCT ID:
NCT00005557
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2000-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Sleep-Disordered Breathing in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1545}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2031-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2000-05-25', 'studyFirstSubmitQcDate': '2000-05-25', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cognitive outcomes', 'timeFrame': 'measured at each study visit', 'description': 'A variety of clinical and laboratory assessments measure cognitive outcomes.'}, {'measure': 'gait and balance', 'timeFrame': 'measured at each study visit', 'description': 'A series of walking tests are conducted.'}, {'measure': 'mental health outcomes', 'timeFrame': 'evaluated at each study visit', 'description': 'Questionnaires assess mood, depression, and anxiety.'}], 'primaryOutcomes': [{'measure': 'sleep disorders and problems, cardiovascular and cognitive outcomes', 'timeFrame': 'measured at each study visit', 'description': 'Overnight polysomnography is used to assess sleep pathology. Questionnaires are used to assess sleep habits. A variety of clinical and laboratory assessments measure cardiovascular and cognitive outcomes.'}], 'secondaryOutcomes': [{'measure': 'cardiovascular outcomes', 'timeFrame': 'measured at each study visit', 'description': 'A variety of clinical and laboratory assessments measure cardiovascular outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Disorders', 'Cerebrovascular Disorders', 'Cardiovascular Disease', 'Neurologic Disorders', 'Mood Disorders']}, 'referencesModule': {'references': [{'pmid': '10805822', 'type': 'BACKGROUND', 'citation': 'Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.'}, {'pmid': '11122588', 'type': 'BACKGROUND', 'citation': 'Peppard PE, Young T, Palta M, Dempsey J, Skatrud J. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA. 2000 Dec 20;284(23):3015-21. doi: 10.1001/jama.284.23.3015.'}, {'pmid': '11427099', 'type': 'BACKGROUND', 'citation': 'Young T, Finn L, Palta M. Chronic nasal congestion at night is a risk factor for snoring in a population-based cohort study. Arch Intern Med. 2001 Jun 25;161(12):1514-9. doi: 10.1001/archinte.161.12.1514.'}, {'pmid': '11401610', 'type': 'BACKGROUND', 'citation': 'Kadotani H, Kadotani T, Young T, Peppard PE, Finn L, Colrain IM, Murphy GM Jr, Mignot E. Association between apolipoprotein E epsilon4 and sleep-disordered breathing in adults. JAMA. 2001 Jun 13;285(22):2888-90. doi: 10.1001/jama.285.22.2888.'}, {'pmid': '11991871', 'type': 'BACKGROUND', 'citation': 'Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.'}, {'pmid': '14572120', 'type': 'BACKGROUND', 'citation': 'Punjabi NM, Bandeen-Roche K, Young T. Predictors of objective sleep tendency in the general population. Sleep. 2003 Sep;26(6):678-83. doi: 10.1093/sleep/26.6.678.'}, {'pmid': '14572118', 'type': 'BACKGROUND', 'citation': 'Young T, Rabago D, Zgierska A, Austin D, Laurel F. Objective and subjective sleep quality in premenopausal, perimenopausal, and postmenopausal women in the Wisconsin Sleep Cohort Study. Sleep. 2003 Sep;26(6):667-72. doi: 10.1093/sleep/26.6.667.'}, {'pmid': '15447944', 'type': 'BACKGROUND', 'citation': 'Lin L, Finn L, Zhang J, Young T, Mignot E. Angiotensin-converting enzyme, sleep-disordered breathing, and hypertension. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1349-53. doi: 10.1164/rccm.200405-616OC. Epub 2004 Sep 24.'}, {'pmid': '15164902', 'type': 'BACKGROUND', 'citation': 'Peppard PE, Young T. Exercise and sleep-disordered breathing: an association independent of body habitus. Sleep. 2004 May 1;27(3):480-4. doi: 10.1093/sleep/27.3.480.'}, {'pmid': '16192452', 'type': 'BACKGROUND', 'citation': 'Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of sleep apnea and type II diabetes: a population-based study. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1590-5. doi: 10.1164/rccm.200504-637OC. Epub 2005 Sep 28.'}, {'pmid': '16141444', 'type': 'BACKGROUND', 'citation': 'Arzt M, Young T, Finn L, Skatrud JB, Bradley TD. Association of sleep-disordered breathing and the occurrence of stroke. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1447-51. doi: 10.1164/rccm.200505-702OC. Epub 2005 Sep 1.'}, {'pmid': '36413205', 'type': 'DERIVED', 'citation': 'Kuo WC, Bratzke LC, Hagen EW, Hale L, Brown RL, Barnet JH, Peppard PE. Metabolic health disparities driven by financial stress: Behavioural adaptation or modification? Stress Health. 2023 Aug;39(3):614-626. doi: 10.1002/smi.3210. Epub 2022 Dec 1.'}, {'pmid': '35714051', 'type': 'DERIVED', 'citation': 'Kuo WC, Ersig AL, Johnson HM, Brown RL, Oakley LD, Hagen EW, Barnet JH, Peppard PE. Association between stressful life events and non-optimal lipid levels among women with hyperlipidaemia. Eur J Cardiovasc Nurs. 2023 Mar 1;22(2):210-219. doi: 10.1093/eurjcn/zvac032.'}, {'pmid': '33630535', 'type': 'DERIVED', 'citation': 'Kuo WC, Oakley LD, Brown RL, Hagen EW, Barnet JH, Peppard PE, Bratzke LC. Gender Differences in the Relationship Between Financial Stress and Metabolic Abnormalities. Nurs Res. 2021 Mar-Apr 01;70(2):123-131. doi: 10.1097/NNR.0000000000000489.'}]}, 'descriptionModule': {'briefSummary': 'To characterize the natural history and biologic spectrum of sleep disordered breathing (SDB) and other sleep problems and disorders, and test hypotheses regarding the causes and consequences of SDB and other sleep problems and disorders.', 'detailedDescription': 'BACKGROUND:\n\nRecent research has shown that sleep disordered breathing (SDB) is much more common than previously thought. While it is known that in clinic samples, SDB is associated with hypertension, cardiovascular disease and mortality, little is known about the natural history of this disorder, particularly in the general population, nor about the causal role of known risk factors. The knowledge obtained from the results of this study will help advance the field of sleep disorders medicine. Information about longitudinal effects and causal relationships may be applied to clinical situations, thus reducing the morbidity and mortality associated with this disorder.\n\nDESIGN NARRATIVE:\n\nIn this longitudinal study, follow-up polysomnography and other protocols are conducted on an established cohort of men and women (age 30-60 years at the time of initial recruitment in 1989), currently enrolled in the Wisconsin Sleep Cohort Study. The study aims to : 1) describe the natural history of SDB across middle and older age; 2) investigate associations of SDB with early and intermediate markers of cardiovascular dysfunction, damage, and cardiovascular disease; 3) investigate the longitudinal association of SDB in accelerated cognitive decline; 4) investigate the association of SDB and adverse sleep characteristics with age-related risk factors and outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In 1988, employees of 4 Wisconsin state agencies, ages 30-60 years, were surveyed regarding sleep habits and problems by mail. From these data, a sampling frame was constructed and 2884 randomly-selected men and women (of 4896 survey respondents) were invited to participate in the WSC Study. Recruitment for baseline sleep studies occurred from 1989 to 2004.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Employee of one of the 4 Wisconsin state agencies\n* Age 30-60 in 1988\n\nExclusion criteria:\n\n* Current pregnancy\n* Unstable or decompensated cardiopulmonary disease\n* Airway cancer\n* Recent upper respiratory surgery'}, 'identificationModule': {'nctId': 'NCT00005557', 'briefTitle': 'Epidemiology of Sleep-Disordered Breathing in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Epidemiology of Sleep-Disordered Breathing in Adults', 'orgStudyIdInfo': {'id': '2012-0084'}, 'secondaryIdInfos': [{'id': 'R01HL062252', 'link': 'https://reporter.nih.gov/quickSearch/R01HL062252', 'type': 'NIH'}, {'id': 'A538500', 'type': 'OTHER', 'domain': 'UW, Madison'}, {'id': 'SMPH/POP HEALTH SCI/POP HLTH', 'type': 'OTHER', 'domain': 'UW, Madison'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Paul E Peppard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}