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The Link Between Clinical and Physiological Sleep Data and Health-related Outcomes

Examining the Link Between Clinical and Physiological Sleep Data and Health-related Outcomes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03383354
Enrollment
5000
Registered
2017-12-26
Start date
2004-01-01
Completion date
2025-06-30
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cardiovascular Diseases, Hospitalizations, Mortality, Nocturnal Myoclonus Syndrome, Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders

Brief summary

Emerging evidence suggests that sleep-related disturbances such as sleep-disordered breathing (e.g. sleep apnea), sleep fragmentation, abnormal sleep architecture, and periodic limb movements (PLMs) are closely linked with adverse health outcomes such as cardiovascular events, hospital admissions and mortality. However, data supporting some of these associations is inconclusive. The Sunnybrook Health Sciences Centre sleep clinic has collected a detailed set of physiological variables from adults who underwent daytime and overnight sleep studies at the Sunnybrook Health Sciences Centre Sleep Laboratory from 2004 till present. Data exists on more than 5,000 subjects with various disturbances of sleep. The investigators plan to link the Sunnybrook Sleep Laboratory data with various health administrative databases based at the Institute for Clinical Evaluative Sciences (ICES). The primary objective of this study is to determine whether the presence of various findings on polysomnography (e.g. obstructive sleep apnea, sleep structure / fragmentation, physiological characteristics such as arousals and periodic limb movements in sleep) are associated with different adverse health outcomes such as cardiovascular events, cancer, depression, hospital admissions, emergency department visits and mortality.

Detailed description

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.

Interventions

OTHERSleep-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)

Sponsors

Institute for Clinical Evaluative Sciences
CollaboratorOTHER
Ottawa Hospital Research Institute
CollaboratorOTHER
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All consecutive patients who underwent a daytime or night-time sleep study at the Sunnybrook Health Sciences Centre Sleep Laboratory

Exclusion criteria

* Not applicable

Design outcomes

Primary

MeasureTime frameDescription
Composite: cardiovascular events and mortalityFrom initial diagnostic sleep study to March 2018Defined from health administrative data using validated case definition

Secondary

MeasureTime frameDescription
Separate components of the composite outcomeFrom initial diagnostic sleep study to March 2018Defined from health administrative data using validated case definition
Incident and prevalent cancerFrom initial diagnostic sleep study to March 2018Defined from health administrative data using validated case definition
HospitalizationsFrom initial diagnostic sleep study to March 2018Defined from health administrative data using validated case definition
Emergency department visitsFrom initial diagnostic sleep study to March 2018Defined from health administrative data using validated case definition

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026