The Link Between Clinical and Physiological Sleep Data and Health-related Outcomes
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|ClinicalTrials.gov Identifier: NCT03383354|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment|
|Sleep Apnea Syndromes Cardiovascular Diseases Sleep Initiation and Maintenance Disorders Nocturnal Myoclonus Syndrome Hospitalizations Mortality Cancer||Other: Sleep-related disturbances (exposure)|
The investigators will conduct a population-based cohort study using linked provincial health administrative data (based at ICES) and clinical sleep data from the Sunnybrook Health Sciences Centre Sleep Laboratory.
ICES holds an individual-level, longitudinal, coded, linkable and secure and privacy protected health databases on most publicly funded health services for the Ontario population eligible for universal health coverage since 1991 (http://www.ices.on.ca/Data-and-Privacy/ICES-data). The records in ICES data include information on physician claims submitted to the Ontario Health Insurance Plan, discharge summaries of emergency department visits and hospital stays and for those 65 years and older medical drug claims to the Ontario Drug Benefit Program. These databases will be linked using unique encoded identifiers and analysed at ICES.
In Ontario, details on physician and hospital services are captured in several health administrative databases; of these databases, the investigators plan to use the following datasets among others: (i) the Ontario Health Insurance Plan (OHIP) physician services database; (ii) the Canadian Institute for Health Information Discharge Abstract Database; (iii) the Ontario Registered Persons Database; (iv) Ontario Registrar General - Death (Vital Stats); and (v) the Ontario Stroke Registry.
ICES is a prescribed entity under section 45 of Ontario's Personal Health Information Protection Act (PHIPA). Section 45 is the provision that enables analysis and compilation of statistical information related to the management, evaluation and monitoring of, allocation of resources to, and planning for the health system. Section 45 authorizes health information custodians to disclose personal health information to a prescribed entity, like ICES, without consent for such purposes.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Examining the Link Between Clinical and Physiological Sleep Data and Health-related Outcomes|
|Actual Study Start Date :||January 1, 2004|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2022|
- Other: Sleep-related disturbances (exposure)
Sleep-related disturbances such as sleep-disordered breathing (e.g. sleep apnea), sleep fragmentation, abnormal sleep architecture, and periodic limb movements (PLMs)
- Composite: cardiovascular events and mortality [ Time Frame: From initial diagnostic sleep study to March 2018 ]Defined from health administrative data using validated case definition
- Separate components of the composite outcome [ Time Frame: From initial diagnostic sleep study to March 2018 ]Defined from health administrative data using validated case definition
- Incident and prevalent cancer [ Time Frame: From initial diagnostic sleep study to March 2018 ]Defined from health administrative data using validated case definition
- Hospitalizations [ Time Frame: From initial diagnostic sleep study to March 2018 ]Defined from health administrative data using validated case definition
- Emergency department visits [ Time Frame: From initial diagnostic sleep study to March 2018 ]Defined from health administrative data using validated case definition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383354
|Contact: Mark I Boulos, MD MScemail@example.com|
|Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Mark I Boulos, MD, MSc 4164804473 firstname.lastname@example.org|
|Principal Investigator:||Tetyana Kendzerska, MD PhD||University of Ottawa|