- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005275
Sleep Heart Health Study (SHHS) Data Coordinating Center (SHHS)
The Sleep Heart Health Study (SHHS) Was a Multi-site Prospective Cohort Study to Investigate Obstructive Sleep Apnea (OSA) and Other Sleep-disordered Breathing (SDB) as Risk Factors for Cardiovascular Diseases and Hypertension
Study Overview
Status
Detailed Description
BACKGROUND:
The study was motivated by the increasing recognition of the frequent occurrences of sleep-disordered breathing in the general population and mounting evidence that sleep-disordered breathing may increase risk for cardiovascular diseases, including coronary artery disease and stroke, and for hypertension, and may reduce quality of life generally. Many clinical questions remain unanswered concerning sleep-disordered breathing as well: for example, when, in the natural history of the disorder, intervention is warranted; and how to determine who is at risk so that recently developed treatments can be applied in a cost-effective manner.
The initiative was developed by the Pulmonary Diseases Advisory Committee, approved by the full Committee in February, 1993, and given concept clearance by the October, 1993 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in January, 1994.
DESIGN NARRATIVE:
The SHHS adds in-home polysomnography to the data collected in each of the cohorts under study. Using the Compumedics SleepWatch polysomnograph, a single over-night polysomnogram is obtained at home for the subjects; the montage includes oximetry, heart rate, chest wall and abdominal movement, nasal/oral airflow, body position, EEG, ECG, and chin EMG. In-home monitoring provides data on the occurrence of sleep-disordered breathing and on arousals.
Although the SHHS is a prospective cohort study, the cross-sectional findings will provide new information on patterns of sleep and sleep-disordered breathing in the general population. Consequently, initial analyses will be descriptive and will also address cross-sectional associations of sleep-disordered breathing with prevalent cardiovascular disease and quality of life and with risk factors for cardiovascular disease. Longitudinal analyses will address sleep-disordered breathing as a predictor of cardiovascular outcomes and change in blood pressure.
The extent of information available on key cardiovascular risk factors varies among the parent cohorts. Some additional data are collected on covariates at enrollment into the SHHS. However, the parent studies are the principal source of information on risk factors for cardiovascular disease in the participants. The cardiovascular outcomes for all sites include hospitalized acute myocardial infarction, nonfatal coronary heart disease, stroke, and death due to cardiovascular or cerebrovascular disease. Change in blood pressure and diagnosis of hypertension is considered, and all participants complete a standardized instrument on quality of life. The cardiovascular outcomes are adjudicated by methods already in place for the ARIC, CHS, SHS, and Framingham Field Centers and by the CHS process for the New York and Tucson Field Centers. Ancillary studies address other outcomes, such as cognitive functioning, that cannot be considered in the full SHHS cohort.
STATUS:
Over 80 manuscripts were published based on substudies and ancillary investigations. Three primary outcomes papers were published in 2009 and 2010, based on follow-up as of 2006-2007.
The study was renewed several times to provide for continued data collection and follow-up, including new polysomnograms. The formal funding for SHHS sites, which ended as of August 31, 2008, was followed by a one-year no- cost extension. Funding ceased for the participating sites as of August 31, 2009, but the Data Coordinating Center and the PSG Reading Center were granted additional no-cost extensions to support additional data collection from the parent cohorts to obtain follow up through 2009, 2010 or 2011 (depending on the cohort), on all-cause mortality, incident CVD, and stroke. The updated results were presented in a session at the ATS 2012 meetings in San Francisco.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants in SHHS were recruited from NHLBI cohort studies already in progress. Parent cohort studies and recruitment targets for these cohorts were as follows:
- Atherosclerosis Risk in Communities Study (ARIC) - 1,750 participants
- Cardiovascular Health Study (CHS) - 1,350 participants
- Framingham Heart Study (FHS) - 1,000 participants
- Strong Heart Study (SHS) - 600 participants
- New York Hypertension Cohorts - 1,000 participants
- Tucson Epidemiologic Study of Airways Obstructive Diseases and the Health and Environment Study - 900 participants
Description
Inclusion Criteria:
- Aged 40 years and older
- Able and willing to undergo a home polysomnogram
Exclusion Criteria:
- Age < 40 years
- Unwillingness, or social, physical or mental condition precluding a home polysomnogram
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-Cause Mortality
Time Frame: 1998-2011
|
Mortality subsequent to polysomnography performed in phase 1(1998-2000) for 6441 participants and in phase 2 (2001-2003) for 4381 participants.
The latest follow-up data were collected from the parent cohorts in 2009-2011.
|
1998-2011
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalent cardiovascular events and stroke
Time Frame: 1998-2011
|
1998-2011
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Rapoport, MD, NYU Langone Health
- Principal Investigator: Susan Redline, MD, MPH, Brigham and Women's Hospital
- Principal Investigator: George O'Connor, MD, MS, Boston University
- Principal Investigator: Naresh Punjabi, MD, PhD, Johns Hopkins University
- Study Chair: Stuart Quan, MD, Harvard Medical School (HMS and HSDM)
- Principal Investigator: Helaine Resnick, PhD, Leading Age
- Principal Investigator: John Robbins, MD, University of California, Davis
- Principal Investigator: Jonathan Samet, MD, MS, University of Southern California
- Principal Investigator: Eyal Shahar, MD, MPH, University of Arizona
- Principal Investigator: Marie Diener-West, PhD, Johns Hopkins University
- Principal Investigator: Anne Newman, MD, MPH, University of Pittsburgh
Publications and helpful links
General Publications
- Zhang L, Samet J, Caffo B, Punjabi NM. Cigarette smoking and nocturnal sleep architecture. Am J Epidemiol. 2006 Sep 15;164(6):529-37. doi: 10.1093/aje/kwj231. Epub 2006 Jul 7.
- Caffo B, Diener-West M, Punjabi NM, Samet J. A novel approach to prediction of mild obstructive sleep disordered breathing in a population-based sample: the Sleep Heart Health Study. Sleep. 2010 Dec;33(12):1641-8. doi: 10.1093/sleep/33.12.1641.
- Monahan K, Storfer-Isser A, Mehra R, Shahar E, Mittleman M, Rottman J, Punjabi N, Sanders M, Quan SF, Resnick H, Redline S. Triggering of nocturnal arrhythmias by sleep-disordered breathing events. J Am Coll Cardiol. 2009 Nov 3;54(19):1797-804. doi: 10.1016/j.jacc.2009.06.038.
- 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.
- Resnick HE, Redline S, Shahar E, Gilpin A, Newman A, Walter R, Ewy GA, Howard BV, Punjabi NM; Sleep Heart Health Study. Diabetes and sleep disturbances: findings from the Sleep Heart Health Study. Diabetes Care. 2003 Mar;26(3):702-9. doi: 10.2337/diacare.26.3.702.
- Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
- Shahar E, Whitney CW, Redline S, Lee ET, Newman AB, Nieto FJ, O'Connor GT, Boland LL, Schwartz JE, Samet JM. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study. Am J Respir Crit Care Med. 2001 Jan;163(1):19-25. doi: 10.1164/ajrccm.163.1.2001008.
- Winkelman JW, Redline S, Baldwin CM, Resnick HE, Newman AB, Gottlieb DJ. Polysomnographic and health-related quality of life correlates of restless legs syndrome in the Sleep Heart Health Study. Sleep. 2009 Jun;32(6):772-8. doi: 10.1093/sleep/32.6.772.
- Fass R, Quan SF, O'Connor GT, Ervin A, Iber C. Predictors of heartburn during sleep in a large prospective cohort study. Chest. 2005 May;127(5):1658-66. doi: 10.1378/chest.127.5.1658.
- Baldwin CM, Griffith KA, Nieto FJ, O'Connor GT, Walsleben JA, Redline S. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep. 2001 Feb 1;24(1):96-105. doi: 10.1093/sleep/24.1.96.
- Gottlieb DJ, Punjabi NM, Newman AB, Resnick HE, Redline S, Baldwin CM, Nieto FJ. Association of sleep time with diabetes mellitus and impaired glucose tolerance. Arch Intern Med. 2005 Apr 25;165(8):863-7. doi: 10.1001/archinte.165.8.863.
- Silva GE, Goodwin JL, Sherrill DL, Arnold JL, Bootzin RR, Smith T, Walsleben JA, Baldwin CM, Quan SF. Relationship between reported and measured sleep times: the sleep heart health study (SHHS). J Clin Sleep Med. 2007 Oct 15;3(6):622-30.
- Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.
- Quan SF, O'Connor GT, Quan JS, Redline S, Resnick HE, Shahar E, Siscovick D, Sherrill DL. Association of physical activity with sleep-disordered breathing. Sleep Breath. 2007 Sep;11(3):149-57. doi: 10.1007/s11325-006-0095-5.
- Punjabi NM, Shahar E, Redline S, Gottlieb DJ, Givelber R, Resnick HE; Sleep Heart Health Study Investigators. Sleep-disordered breathing, glucose intolerance, and insulin resistance: the Sleep Heart Health Study. Am J Epidemiol. 2004 Sep 15;160(6):521-30. doi: 10.1093/aje/kwh261.
- Gottlieb DJ, DeStefano AL, Foley DJ, Mignot E, Redline S, Givelber RJ, Young T. APOE epsilon4 is associated with obstructive sleep apnea/hypopnea: the Sleep Heart Health Study. Neurology. 2004 Aug 24;63(4):664-8. doi: 10.1212/01.wnl.0000134671.99649.32.
- Redline S, Sanders MH, Lind BK, Quan SF, Iber C, Gottlieb DJ, Bonekat WH, Rapoport DM, Smith PL, Kiley JP. Methods for obtaining and analyzing unattended polysomnography data for a multicenter study. Sleep Heart Health Research Group. Sleep. 1998 Nov 1;21(7):759-67.
- Whitney CW, Gottlieb DJ, Redline S, Norman RG, Dodge RR, Shahar E, Surovec S, Nieto FJ. Reliability of scoring respiratory disturbance indices and sleep staging. Sleep. 1998 Nov 1;21(7):749-57. doi: 10.1093/sleep/21.7.749.
- Gottlieb DJ, Whitney CW, Bonekat WH, Iber C, James GD, Lebowitz M, Nieto FJ, Rosenberg CE. Relation of sleepiness to respiratory disturbance index: the Sleep Heart Health Study. Am J Respir Crit Care Med. 1999 Feb;159(2):502-7. doi: 10.1164/ajrccm.159.2.9804051.
- Quan SF, Howard BV, Iber C, Kiley JP, Nieto FJ, O'Connor GT, Rapoport DM, Redline S, Robbins J, Samet JM, Wahl PW. The Sleep Heart Health Study: design, rationale, and methods. Sleep. 1997 Dec;20(12):1077-85.
- Whitney CW, Lind BK, Wahl PW. Quality assurance and quality control in longitudinal studies. Epidemiol Rev. 1998;20(1):71-80. doi: 10.1093/oxfordjournals.epirev.a017973.
- Redline S, Sanders M. Hypopnea, a floating metric: implications for prevalence, morbidity estimates, and case finding. Sleep. 1997 Dec;20(12):1209-17. doi: 10.1093/sleep/20.12.1209.
- Redline S, Kapur VK, Sanders MH, Quan SF, Gottlieb DJ, Rapoport DM, Bonekat WH, Smith PL, Kiley JP, Iber C. Effects of varying approaches for identifying respiratory disturbances on sleep apnea assessment. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):369-74. doi: 10.1164/ajrccm.161.2.9904031.
- Newman AB, Nieto FJ, Guidry U, Lind BK, Redline S, Pickering TG, Quan SF; Sleep Heart Health Study Research Group. Relation of sleep-disordered breathing to cardiovascular disease risk factors: the Sleep Heart Health Study. Am J Epidemiol. 2001 Jul 1;154(1):50-9. doi: 10.1093/aje/154.1.50.
- Kapur VK, Rapoport DM, Sanders MH, Enright P, Hill J, Iber C, Romaniuk J. Rates of sensor loss in unattended home polysomnography: the influence of age, gender, obesity, and sleep-disordered breathing. Sleep. 2000 Aug 1;23(5):682-8.
- Gottlieb DJ, Yao Q, Redline S, Ali T, Mahowald MW. Does snoring predict sleepiness independently of apnea and hypopnea frequency? Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1512-7. doi: 10.1164/ajrccm.162.4.9911073.
- Young T, Shahar E, Nieto FJ, Redline S, Newman AB, Gottlieb DJ, Walsleben JA, Finn L, Enright P, Samet JM; Sleep Heart Health Study Research Group. Predictors of sleep-disordered breathing in community-dwelling adults: the Sleep Heart Health Study. Arch Intern Med. 2002 Apr 22;162(8):893-900. doi: 10.1001/archinte.162.8.893.
- Kapur VK, Redline S, Nieto FJ, Young TB, Newman AB, Henderson JA; Sleep Heart Health Research Group. The relationship between chronically disrupted sleep and healthcare use. Sleep. 2002 May 1;25(3):289-96.
- Boland LL, Shahar E, Iber C, Knopman DS, Kuo TF, Nieto FJ; Sleep Heart Health Study (SHHS) Investigators. Measures of cognitive function in persons with varying degrees of sleep-disordered breathing: the Sleep Heart Health Study. J Sleep Res. 2002 Sep;11(3):265-72. doi: 10.1046/j.1365-2869.2002.00308.x.
- Sanders MH, Newman AB, Haggerty CL, Redline S, Lebowitz M, Samet J, O'Connor GT, Punjabi NM, Shahar E; Sleep Heart Health Study. Sleep and sleep-disordered breathing in adults with predominantly mild obstructive airway disease. Am J Respir Crit Care Med. 2003 Jan 1;167(1):7-14. doi: 10.1164/rccm.2203046.
- Quan SF, Griswold ME, Iber C, Nieto FJ, Rapoport DM, Redline S, Sanders M, Young T; Sleep Heart Health Study (SHHS) Research Group. Short-term variability of respiration and sleep during unattended nonlaboratory polysomnography--the Sleep Heart Health Study. [corrected]. Sleep. 2002 Dec;25(8):843-9. Erratum In: Sleep. 2009 Oct 1;32(10):table of contents.
- Shahar E, Redline S, Young T, Boland LL, Baldwin CM, Nieto FJ, O'Connor GT, Rapoport DM, Robbins JA. Hormone replacement therapy and sleep-disordered breathing. Am J Respir Crit Care Med. 2003 May 1;167(9):1186-92. doi: 10.1164/rccm.200210-1238OC. Epub 2003 Jan 16.
- Lind BK, Goodwin JL, Hill JG, Ali T, Redline S, Quan SF. Recruitment of healthy adults into a study of overnight sleep monitoring in the home: experience of the Sleep Heart Health Study. Sleep Breath. 2003 Mar;7(1):13-24. doi: 10.1007/s11325-003-0013-z.
- O'Connor GT, Lind BK, Lee ET, Nieto FJ, Redline S, Samet JM, Boland LL, Walsleben JA, Foster GL; Sleep Heart Health Study Investigators. Variation in symptoms of sleep-disordered breathing with race and ethnicity: the Sleep Heart Health Study. Sleep. 2003 Feb 1;26(1):74-9.
- Nieto FJ, Herrington DM, Redline S, Benjamin EJ, Robbins JA. Sleep apnea and markers of vascular endothelial function in a large community sample of older adults. Am J Respir Crit Care Med. 2004 Feb 1;169(3):354-60. doi: 10.1164/rccm.200306-756OC. Epub 2003 Oct 9.
- Walsleben JA, Kapur VK, Newman AB, Shahar E, Bootzin RR, Rosenberg CE, O'Connor G, Nieto FJ. Sleep and reported daytime sleepiness in normal subjects: the Sleep Heart Health Study. Sleep. 2004 Mar 15;27(2):293-8. doi: 10.1093/sleep/27.2.293.
- Kapur V, Strohl KP, Redline S, Iber C, O'Connor G, Nieto J. Underdiagnosis of sleep apnea syndrome in U.S. communities. Sleep Breath. 2002 Jun;6(2):49-54. doi: 10.1007/s11325-002-0049-5.
- Iber C, Redline S, Kaplan Gilpin AM, Quan SF, Zhang L, Gottlieb DJ, Rapoport D, Resnick HE, Sanders M, Smith P. Polysomnography performed in the unattended home versus the attended laboratory setting--Sleep Heart Health Study methodology. Sleep. 2004 May 1;27(3):536-40. doi: 10.1093/sleep/27.3.536.
- Boland LL, Shahar E, Wong TY, Klein R, Punjabi N, Robbins JA, Newman AB. Sleep-disordered breathing is not associated with the presence of retinal microvascular abnormalities: the Sleep Heart Health Study. Sleep. 2004 May 1;27(3):467-73. doi: 10.1093/sleep/27.3.467.
- Redline S, Kirchner HL, Quan SF, Gottlieb DJ, Kapur V, Newman A. The effects of age, sex, ethnicity, and sleep-disordered breathing on sleep architecture. Arch Intern Med. 2004 Feb 23;164(4):406-18. doi: 10.1001/archinte.164.4.406.
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- Haas DC, Foster GL, Nieto FJ, Redline S, Resnick HE, Robbins JA, Young T, Pickering TG. Age-dependent associations between sleep-disordered breathing and hypertension: importance of discriminating between systolic/diastolic hypertension and isolated systolic hypertension in the Sleep Heart Health Study. Circulation. 2005 Feb 8;111(5):614-21. doi: 10.1161/01.CIR.0000154540.62381.CF.
- Ding J, Nieto FJ, Beauchamp NJ Jr, Harris TB, Robbins JA, Hetmanski JB, Fried LP, Redline S. Sleep-disordered breathing and white matter disease in the brainstem in older adults. Sleep. 2004 May 1;27(3):474-9. doi: 10.1093/sleep/27.3.474.
- Levy AP, Zhang L, Miller-Lotan R, Redline S, O'Connor GT, Quan SF, Resnick HE. Haptoglobin phenotype, sleep-disordered breathing, and the prevalence of cardiovascular disease: the Sleep Heart Health Study. Sleep. 2005 Feb;28(2):207-13. doi: 10.1093/sleep/28.2.207.
- Newman AB, Foster G, Givelber R, Nieto FJ, Redline S, Young T. Progression and regression of sleep-disordered breathing with changes in weight: the Sleep Heart Health Study. Arch Intern Med. 2005 Nov 14;165(20):2408-13. doi: 10.1001/archinte.165.20.2408.
- Robbins J, Redline S, Ervin A, Walsleben JA, Ding J, Nieto FJ. Associations of sleep-disordered breathing and cerebral changes on MRI. J Clin Sleep Med. 2005 Apr 15;1(2):159-65.
- Redline S, Min NI, Shahar E, Rapoport D, O'Connor G. Polysomnographic predictors of blood pressure and hypertension: is one index best? Sleep. 2005 Sep;28(9):1122-30. doi: 10.1093/sleep/28.9.1122.
- Gottlieb DJ, Redline S, Nieto FJ, Baldwin CM, Newman AB, Resnick HE, Punjabi NM. Association of usual sleep duration with hypertension: the Sleep Heart Health Study. Sleep. 2006 Aug;29(8):1009-14. doi: 10.1093/sleep/29.8.1009.
- Quan SF, Wright R, Baldwin CM, Kaemingk KL, Goodwin JL, Kuo TF, Kaszniak A, Boland LL, Caccappolo E, Bootzin RR. Obstructive sleep apnea-hypopnea and neurocognitive functioning in the Sleep Heart Health Study. Sleep Med. 2006 Sep;7(6):498-507. doi: 10.1016/j.sleep.2006.02.005. Epub 2006 Jul 3.
- Patwardhan AA, Larson MG, Levy D, Benjamin EJ, Leip EP, Keyes MJ, Wang TJ, Gottlieb DJ, Vasan RS. Obstructive sleep apnea and plasma natriuretic peptide levels in a community-based sample. Sleep. 2006 Oct;29(10):1301-6. doi: 10.1093/sleep/29.10.1301.
- Unruh ML, Sanders MH, Redline S, Piraino BM, Umans JG, Hammond TC, Sharief I, Punjabi NM, Newman AB. Sleep apnea in patients on conventional thrice-weekly hemodialysis: comparison with matched controls from the Sleep Heart Health Study. J Am Soc Nephrol. 2006 Dec;17(12):3503-9. doi: 10.1681/ASN.2006060659. Epub 2006 Nov 2.
- Wattanakit K, Boland L, Punjabi NM, Shahar E. Relation of sleep-disordered breathing to carotid plaque and intima-media thickness. Atherosclerosis. 2008 Mar;197(1):125-31. doi: 10.1016/j.atherosclerosis.2007.02.029. Epub 2007 Apr 11.
- Gottlieb DJ, O'Connor GT, Wilk JB. Genome-wide association of sleep and circadian phenotypes. BMC Med Genet. 2007 Sep 19;8 Suppl 1(Suppl 1):S9. doi: 10.1186/1471-2350-8-S1-S9.
- Zhang L, Samet J, Caffo B, Bankman I, Punjabi NM. Power spectral analysis of EEG activity during sleep in cigarette smokers. Chest. 2008 Feb;133(2):427-32. doi: 10.1378/chest.07-1190. Epub 2007 Oct 9.
- Winkelman JW, Shahar E, Sharief I, Gottlieb DJ. Association of restless legs syndrome and cardiovascular disease in the Sleep Heart Health Study. Neurology. 2008 Jan 1;70(1):35-42. doi: 10.1212/01.wnl.0000287072.93277.c9.
- Seicean S, Kirchner HL, Gottlieb DJ, Punjabi NM, Resnick H, Sanders M, Budhiraja R, Singer M, Redline S. Sleep-disordered breathing and impaired glucose metabolism in normal-weight and overweight/obese individuals: the Sleep Heart Health Study. Diabetes Care. 2008 May;31(5):1001-6. doi: 10.2337/dc07-2003. Epub 2008 Feb 11.
- Chami HA, Devereux RB, Gottdiener JS, Mehra R, Roman MJ, Benjamin EJ, Gottlieb DJ. Left ventricular morphology and systolic function in sleep-disordered breathing: the Sleep Heart Health Study. Circulation. 2008 May 20;117(20):2599-607. doi: 10.1161/CIRCULATIONAHA.107.717892. Epub 2008 May 5.
- Punjabi NM, Newman AB, Young TB, Resnick HE, Sanders MH. Sleep-disordered breathing and cardiovascular disease: an outcome-based definition of hypopneas. Am J Respir Crit Care Med. 2008 May 15;177(10):1150-5. doi: 10.1164/rccm.200712-1884OC. Epub 2008 Feb 14.
- Unruh ML, Redline S, An MW, Buysse DJ, Nieto FJ, Yeh JL, Newman AB. Subjective and objective sleep quality and aging in the sleep heart health study. J Am Geriatr Soc. 2008 Jul;56(7):1218-27. doi: 10.1111/j.1532-5415.2008.01755.x. Epub 2008 May 14.
- Kapur VK, Resnick HE, Gottlieb DJ; Sleep Heart Health Study Group. Sleep disordered breathing and hypertension: does self-reported sleepiness modify the association? Sleep. 2008 Aug;31(8):1127-32.
- Stamatakis K, Sanders MH, Caffo B, Resnick HE, Gottlieb DJ, Mehra R, Punjabi NM. Fasting glycemia in sleep disordered breathing: lowering the threshold on oxyhemoglobin desaturation. Sleep. 2008 Jul;31(7):1018-24.
- Unruh ML, Sanders MH, Redline S, Piraino BM, Umans JG, Chami H, Budhiraja R, Punjabi NM, Buysse D, Newman AB. Subjective and objective sleep quality in patients on conventional thrice-weekly hemodialysis: comparison with matched controls from the sleep heart health study. Am J Kidney Dis. 2008 Aug;52(2):305-13. doi: 10.1053/j.ajkd.2008.04.019. Epub 2008 Jul 9.
- Sharief I, Silva GE, Goodwin JL, Quan SF. Effect of sleep disordered breathing on the sleep of bed partners in the Sleep Heart Health Study. Sleep. 2008 Oct;31(10):1449-56.
- O'Connor GT, Caffo B, Newman AB, Quan SF, Rapoport DM, Redline S, Resnick HE, Samet J, Shahar E. Prospective study of sleep-disordered breathing and hypertension: the Sleep Heart Health Study. Am J Respir Crit Care Med. 2009 Jun 15;179(12):1159-64. doi: 10.1164/rccm.200712-1809OC. Epub 2009 Mar 5.
- Silva GE, An MW, Goodwin JL, Shahar E, Redline S, Resnick H, Baldwin CM, Quan SF. Longitudinal evaluation of sleep-disordered breathing and sleep symptoms with change in quality of life: the Sleep Heart Health Study (SHHS). Sleep. 2009 Aug;32(8):1049-57. doi: 10.1093/sleep/32.8.1049.
- Chami HA, Keyes MJ, Vita JA, Mitchell GF, Larson MG, Fan S, Vasan RS, O'Connor GT, Benjamin EJ, Gottlieb DJ. Brachial artery diameter, blood flow and flow-mediated dilation in sleep-disordered breathing. Vasc Med. 2009 Nov;14(4):351-60. doi: 10.1177/1358863X09105132.
- Caffo B, Swihart B, Laffan A, Crainiceanu C, Punjabi N. An overview of observational sleep research with application to sleep stage transitioning. Chance (N Y). 2009 Mar 1;22(1):10-15. doi: 10.1007/s144-009-0002-5. No abstract available.
- Thomas RJ, Weiss MD, Mietus JE, Peng CK, Goldberger AL, Gottlieb DJ. Prevalent hypertension and stroke in the Sleep Heart Health Study: association with an ECG-derived spectrographic marker of cardiopulmonary coupling. Sleep. 2009 Jul;32(7):897-904.
- Chami HA, Baldwin CM, Silverman A, Zhang Y, Rapoport D, Punjabi NM, Gottlieb DJ. Sleepiness, quality of life, and sleep maintenance in REM versus non-REM sleep-disordered breathing. Am J Respir Crit Care Med. 2010 May 1;181(9):997-1002. doi: 10.1164/rccm.200908-1304OC. Epub 2010 Jan 21. Erratum In: Am J Respir Crit Care Med. 2011 Sep 1;184(5):622.
- Baldwin CM, Ervin AM, Mays MZ, Robbins J, Shafazand S, Walsleben J, Weaver T. Sleep disturbances, quality of life, and ethnicity: the Sleep Heart Health Study. J Clin Sleep Med. 2010 Apr 15;6(2):176-83.
- Zanobetti A, Redline S, Schwartz J, Rosen D, Patel S, O'Connor GT, Lebowitz M, Coull BA, Gold DR. Associations of PM10 with sleep and sleep-disordered breathing in adults from seven U.S. urban areas. Am J Respir Crit Care Med. 2010 Sep 15;182(6):819-25. doi: 10.1164/rccm.200912-1797OC. Epub 2010 May 27.
- Larkin EK, Patel SR, Zhu X, Tracy RP, Jenny NS, Reiner AP, Walston J, Redline S. Study of the relationship between the interleukin-6 gene and obstructive sleep apnea. Clin Transl Sci. 2010 Dec;3(6):337-9. doi: 10.1111/j.1752-8062.2010.00236.x.
- Laffan A, Caffo B, Swihart BJ, Punjabi NM. Utility of sleep stage transitions in assessing sleep continuity. Sleep. 2010 Dec;33(12):1681-6. doi: 10.1093/sleep/33.12.1681.
- Chami HA, Resnick HE, Quan SF, Gottlieb DJ. Association of incident cardiovascular disease with progression of sleep-disordered breathing. Circulation. 2011 Mar 29;123(12):1280-6. doi: 10.1161/CIRCULATIONAHA.110.974022. Epub 2011 Mar 14.
- Bruce EN, Bruce MC, Ramanand P, Hayes D Jr. Progressive changes in cortical state before and after spontaneous arousals from sleep in elderly and middle-aged women. Neuroscience. 2011 Feb 23;175:184-97. doi: 10.1016/j.neuroscience.2010.11.036. Epub 2010 Nov 27.
- Silva GE, Vana KD, Goodwin JL, Sherrill DL, Quan SF. Identification of patients with sleep disordered breathing: comparing the four-variable screening tool, STOP, STOP-Bang, and Epworth Sleepiness Scales. J Clin Sleep Med. 2011 Oct 15;7(5):467-72. doi: 10.5664/JCSM.1308.
- Parthasarathy S, Fitzgerald M, Goodwin JL, Unruh M, Guerra S, Quan SF. Nocturia, sleep-disordered breathing, and cardiovascular morbidity in a community-based cohort. PLoS One. 2012;7(2):e30969. doi: 10.1371/journal.pone.0030969. Epub 2012 Feb 6.
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Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Myocardial Infarction
- Infarction
- Heart Diseases
- Stroke
- Coronary Disease
- Sleep Apnea Syndromes
- Hypertension
- Cardiovascular Diseases
- Lung Diseases
Other Study ID Numbers
- 1302
- U01HL053941-14 (U.S. NIH Grant/Contract)
- U01HL053941 (U.S. NIH Grant/Contract)
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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