Sleep Apnea SyndromesNCT03383354
The Link Between Clinical and Physiological Sleep Data and Health-related Outcomes
An observational study of Sleep Apnea Syndromes and Cardiovascular Diseases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Cardiovascular Diseases, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Sleep-related disturbances (exposure)
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2004to Jun 2025
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All consecutive patients who underwent a daytime or night-time sleep study at the Sunnybrook Health Sciences Centre Sleep Laboratory
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
About this study
Official title: Examining the Link Between Clinical and Physiological Sleep Data and Health-related Outcomes
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.
Read the 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.
- Conditions
- Sleep Apnea Syndromes, Cardiovascular Diseases, Sleep Initiation and Maintenance Disorders, Nocturnal Myoclonus Syndrome, Hospitalizations, Mortality
- Being tested
- Sleep-related disturbances (exposure)
- Medical subject headings
- Sleep Apnea Syndromes, Cardiovascular Diseases, Sleep Initiation and Maintenance Disorders, Nocturnal Myoclonus Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep-related disturbances (exposure)Other
Sleep-related disturbances such as sleep-disordered breathing (e.g. sleep apnea), sleep fragmentation, abnormal sleep architecture, and periodic limb movements (PLMs)
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite: cardiovascular events and mortality
Defined from health administrative data using validated case definition
Measured: From initial diagnostic sleep study to March 2018
Secondary outcomes (4)
Separate components of the composite outcome
Defined from health administrative data using validated case definition
Measured: From initial diagnostic sleep study to March 2018
Incident and prevalent cancer
Defined from health administrative data using validated case definition
Measured: From initial diagnostic sleep study to March 2018
Hospitalizations
Defined from health administrative data using validated case definition
Measured: From initial diagnostic sleep study to March 2018
Emergency department visits
Defined from health administrative data using validated case definition
Measured: From initial diagnostic sleep study to March 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jan 2004
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies 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
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Tetyana Kendzerska, MD PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383354
- Sponsor's protocol ID
- 095-2016
- Status last verified
- Nov 2023
- First submitted
- 19 Dec 2017
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kendzerska T, Murray BJ, Gershon AS, Povitz M, McIsaac DI, Bryson GL, Talarico R, Hilton J, Malhotra A, Leung RS, Boulos MI. Polysomnographic Assessment of Sleep Disturbances in Cancer Development: A Historical Multicenter Clinical Cohort Study. Chest. 2023 Aug;164(2):517-530. doi: 10.1016/j.chest.2023.03.006. Epub 2023 Mar 11.
PubMed 36907376