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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
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

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)

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.


Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
    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)


Primary Outcome Measures :
  1. Composite: cardiovascular events and mortality [ Time Frame: From initial diagnostic sleep study to March 2018 ]
    Defined from health administrative data using validated case definition


Secondary Outcome Measures :
  1. 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

  2. Incident and prevalent cancer [ Time Frame: From initial diagnostic sleep study to March 2018 ]
    Defined from health administrative data using validated case definition

  3. Hospitalizations [ Time Frame: From initial diagnostic sleep study to March 2018 ]
    Defined from health administrative data using validated case definition

  4. Emergency department visits [ Time Frame: From initial diagnostic sleep study to March 2018 ]
    Defined from health administrative data using validated case definition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will retrospectively analyze data from patients who underwent a daytime or night-time sleep study at the Sunnybrook Health Sciences Centre Sleep Laboratory. We plan to link sleep-related data using patients' last and first name, date of birth, gender and postal code, to health administrative data housed at the Institute for Clinical Evaluative Sciences (ICES). The full date of birth and full postal code are required to establish precise linkages with ICES outcomes data.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

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


Contacts
Contact: Mark I Boulos, MD MSc 4164804473 mark.boulos@utoronto.ca

Locations
Canada, Ontario
Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Mark I Boulos, MD, MSc    4164804473    mark.boulos@utoronto.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Institute for Clinical Evaluative Sciences
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Tetyana Kendzerska, MD PhD University of Ottawa

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03383354     History of Changes
Other Study ID Numbers: 095-2016
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Cardiovascular Diseases
Sleep Apnea Syndromes
Sleep Initiation and Maintenance Disorders
Myoclonus
Nocturnal Myoclonus Syndrome
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Parasomnias