Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03383354 |
| Other study ID # |
095-2016 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2004 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
