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

NCT03383354 | Unknown

• 1 other identifier: 095-2016
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Composite: cardiovascular events and mortality

  Defined from health administrative data using validated case definition

  From initial diagnostic sleep study to March 2018

Secondary Outcomes (4)

• Separate components of the composite outcome

  From initial diagnostic sleep study to March 2018

• Incident and prevalent cancer

  From initial diagnostic sleep study to March 2018

• Hospitalizations

  From initial diagnostic sleep study to March 2018

• Emergency department visits

  From initial diagnostic sleep study to March 2018

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Institute for Clinical Evaluative Sciences: collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 36907376 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Cardiovascular Diseases; Sleep Initiation and Maintenance Disorders; Nocturnal Myoclonus Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parasomnias

Study Officials

• Tetyana Kendzerska, MD PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: January 1, 2004
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

CA (1)