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Sleep Heart Health Study (SHHS)
This study has been completed.
First Received: May 25, 2000   Last Updated: April 13, 2009   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005275
  Purpose

To test whether sleep-disordered breathing is associated with an increased risk of coronary heart disease, stroke, all-cause mortality, and hypertension.

The multicenter, longitudinal study draws on existing, well-characterized, and established epidemiologic cohorts.


Condition Phase
Lung Diseases
Sleep Apnea Syndromes
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Cerebrovascular Accident
Hypertension
Myocardial Infarction
N/A

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Diseases High Blood Pressure Sleep Apnea
U.S. FDA Resources
Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1994
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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 will be 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.

Several substudies are underway, including ones on polysomnogram scoring reliability, cognitive function, 24 hour blood pressure monitoring, and urinary catecholamines. .

The study has been renewed several times to provide for continued data collection and follow-up, including new polysomnograms. The study ends in August 2008.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005275

Sponsors and Collaborators
Investigators
Investigator: George O'Connor Boston University
Investigator: Naresh Punjabi Johns Hopkins University
Investigator: Stuart Quan University of Arizona
Investigator: David Rapoport New York University Medical Center
Investigator: Susan Redline Case Western Reserve University
Investigator: Helaine Resnick Missouri Breaks Research, Inc.
Investigator: John Robbins University of California at Davis
Investigator: Jonathan Samet Johns Hopkins University
Investigator: Eyal Shahar University of Minnesota
Investigator: Patricia Wahl University of Washington
  More Information

Publications:
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.
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.
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.
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.
Whitney CW, Lind BK, Wahl PW. Quality assurance and quality control in longitudinal studies. Epidemiol Rev. 1998;20(1):71-80. Review.
Redline S, Sanders M. Hypopnea, a floating metric: implications for prevalence, morbidity estimates, and case finding. Sleep. 1997 Dec;20(12):1209-17. Review.
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.
Shahar E, Whitney CW, Redline S, Lee ET, Newman AB, Javier Nieto F, 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.
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.
Newman AB, Nieto FJ, Guidry U, Lind BK, Redline S, Pickering TG, Quan SF. 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.
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.
Young T, Shahar E, Nieto FJ, Redline S, Newman AB, Gottlieb DJ, Walsleben JA, Finn L, Enright P, Samet JM. Predictors of sleep-disordered breathing in community-dwelling adults: the Sleep Heart Health Study. Arch Intern Med. 2002 Apr 22;162(8):893-900.
Kapur VK, Redline S, Nieto FJ, Young TB, Newman AB, Henderson JA. 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. 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.
Sanders MH, Newman AB, Haggerty CL, Redline S, Lebowitz M, Samet J, O'Connor GT, Punjabi NM, Shahar E. 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.
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.
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 variablility of respiration and sleep during unattended nonlaboratory polysomnogaphy--the Sleep Heart Health Study. Sleep. 2002 Dec15;25(8):843-9.
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. 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.
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, Harrington 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. 2003 Oct 9 [Epub ahead of print]
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.
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.
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.
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.
Nieto FJ, Harrington 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. 2003 Oct 9 [Epub ahead of print]
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.
Punjabi NM, Shahar E, Redline S, Gottlieb DJ, Givelber R, Resnick HE. Sleep-disordered breathing, glucose intolerance, and insulin resistance: the sleep heart health study. Am J Epidemiol. 2004 Sep 15;160(6):521-30.
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.
Valyi-Nagy I, Jensen PJ, Albelda SM, Rodeck U. Cytokine-induced expression of transforming growth factor-alpha and the epidermal growth factor receptor in neonatal skin explants. J Invest Dermatol. 1992 Sep;99(3):350-6.
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.
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.
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.
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.
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 1;28(2):207-13.
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.

Study ID Numbers: 1302
Study First Received: May 25, 2000
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00005275     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Cerebral Infarction
Myocardial Ischemia
Sleep Disorders
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Sleep Disorders, Intrinsic
Necrosis
Respiratory Tract Diseases
Brain Ischemia
Myocardial Infarction
Arterial Occlusive Diseases
Sleep Apnea Syndromes
Heart Diseases
Apnea
Stroke
Respiration Disorders
Vascular Diseases
Central Nervous System Diseases
Dyssomnias
Ischemia
Coronary Disease
Lung Diseases
Brain Infarction
Infarction
Coronary Artery Disease
Hypertension

Additional relevant MeSH terms:
Cerebral Infarction
Myocardial Ischemia
Sleep Disorders
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Sleep Disorders, Intrinsic
Necrosis
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Brain Ischemia
Cardiovascular Diseases
Myocardial Infarction
Arterial Occlusive Diseases
Sleep Apnea Syndromes
Disease
Heart Diseases
Apnea
Nervous System Diseases
Stroke
Respiration Disorders
Vascular Diseases
Central Nervous System Diseases
Dyssomnias
Ischemia
Coronary Disease
Lung Diseases
Brain Infarction
Infarction

ClinicalTrials.gov processed this record on May 07, 2009