Lung DiseasesSHHSNCT00005275
Sleep Heart Health Study (SHHS) Data Coordinating Center
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Diseases, Sleep Apnea Syndromes, Cardiovascular Diseases
- How many people
- 6,441 participants
- Where
- No sites listed yet
- Study dates
- Sep 1994to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Aged 40 years and older
- Able and willing to undergo a home polysomnogram
Who cannot join
- Age < 40 years
- Unwillingness, or social, physical or mental condition precluding a home polysomnogram
About this study
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
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.
Read the 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.
- Conditions
- Lung Diseases, Sleep Apnea Syndromes, Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Accident
- Medical subject headings
- Lung Diseases, Sleep Apnea Syndromes, Cardiovascular Diseases, Heart Diseases, Coronary Disease, Stroke, Hypertension, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
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.
Measured: 1998-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1994
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (96)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marie Diener-West, Johns Hopkins Bloomberg School of Public Health
- Investigators
- George O'Connor, MD, MS, Principal investigator, Boston UniversityNaresh Punjabi, MD, PhD, Principal investigator, Johns Hopkins UniversityStuart Quan, MD, Study chair, Harvard Medical School (HMS and HSDM)David Rapoport, MD, Principal investigator, NYU Langone HealthSusan Redline, MD, MPH, Principal investigator, Brigham and Women's HospitalHelaine Resnick, PhD, Principal investigator, Leading AgeJohn Robbins, MD, Principal investigator, University of California, DavisJonathan Samet, MD, MS, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005275
- Sponsor's protocol ID
- 1302
- Other IDs
- U01HL053941-14, U01HL053941
- Acronym
- SHHS
- Status last verified
- May 2013
- First submitted
- 25 May 2000
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11300121Whitney 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.
PubMed 11286351Gottlieb 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.
PubMed 9927364Quan 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.
PubMed 9493915Nieto 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.
PubMed 10770144Whitney 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.
PubMed 9762510Redline 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.
PubMed 9493935Redline 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.
PubMed 10673173Shahar 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.
PubMed 11208620Baldwin 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.
PubMed 11204058Newman 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.
PubMed 11434366Kapur 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.
PubMed 10947036Gottlieb 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.
PubMed 11029370Young 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.
PubMed 11966340Kapur 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.
PubMed 12003159
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005275
- Acronym / sponsor ID
- SHHS / 1302
- Conditions
- Lung Diseases, Sleep Apnea Syndromes, Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,441 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1994
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Aged 40 years and older
- Able and willing to undergo a home polysomnogram
Key exclusion criteria (2 listed)
- Age < 40 years
- Unwillingness, or social, physical or mental condition precluding a home polysomnogram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Background: PubMed 11300121Redline 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.
- Background: PubMed 11286351Whitney 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.
- Background: PubMed 9927364Gottlieb 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.
- Background: PubMed 9493915Quan 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.
- Background: PubMed 10770144Nieto 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.
- Background: PubMed 9762510Whitney 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.
- Background: PubMed 9493935Redline 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.
- Background: PubMed 10673173Redline 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.
- Background: PubMed 11208620Shahar 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.
- Background: PubMed 11204058Baldwin 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.
- Background: PubMed 11434366Newman 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.
- Background: PubMed 10947036Kapur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George O'Connor, MD, MS principal investigator
Boston University
Naresh Punjabi, MD, PhD principal investigator
Johns Hopkins University
Stuart Quan, MD study chair
Harvard Medical School (HMS and HSDM)
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: 1998-2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005275, which also lists 96 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.