Clinical trial NCT00005275: Sleep Heart Health Study (SHHS) Data Coordinating Center
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Sleep Apnea Syndromes
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Cerebrovascular Accident
Hypertension
Myocardial Infarction
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Enrollment: 6441
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-Cause Mortality
timeFrame: 1998-2011
Secondary outcomes:
Other outcomes:
measure: Prevalent cardiovascular events and stroke
timeFrame: 1998-2011
Locations:
Study officials:
affiliation: Boston University
name: George O'Connor, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Naresh Punjabi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School (HMS and HSDM)
name: Stuart Quan, MD
role: STUDY_CHAIR
affiliation: NYU Langone Health
name: David Rapoport, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Susan Redline, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Leading Age
name: Helaine Resnick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: John Robbins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Jonathan Samet, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Eyal Shahar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Marie Diener-West, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Anne Newman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.
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