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
- Are there results?
- None posted in the registry
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.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Link Between Clinical and Physiological Sleep Data and Health-related Outcomes
- ClinicalTrials.gov ID
- NCT03383354
- Acronym / sponsor ID
- 095-2016
- Conditions
- Sleep Apnea Syndromes, Cardiovascular Diseases, Sleep Initiation and Maintenance Disorders, Nocturnal Myoclonus Syndrome, Hospitalizations, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Ottawa Hospital Research Institute
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All consecutive patients who underwent a daytime or night-time sleep study at the Sunnybrook Health Sciences Centre Sleep Laboratory
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | – |
Primary outcome
Composite: cardiovascular events and mortality
Time frame: From initial diagnostic sleep study to March 2018
Defined from health administrative data using validated case definition
4 secondary outcomes
Separate components of the composite outcome
Time frame: From initial diagnostic sleep study to March 2018
Incident and prevalent cancer
Time frame: From initial diagnostic sleep study to March 2018
Hospitalizations
Time frame: From initial diagnostic sleep study to March 2018
Emergency department visits
Time frame: From initial diagnostic sleep study to March 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 36907376Kendzerska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Kendzerska, MD PhD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes and Cardiovascular Diseases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite: cardiovascular events and mortality (time frame: From initial diagnostic sleep study to March 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.