Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

NCT03834792 | Active Not Recruiting

• 1 other identifier: 20170591-01H
• Study Type: observational
• Target: 5,155
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the proposed study is to validate our previously developed predictive model for adults with obstructive sleep apnea using (i) clinical data from multiple large academic centers, (ii) a longer follow-up period, and (iii) an extended definition of outcomes of interest. The TOH sleep database was created as a part of the project: "Validation of provincial health administrative data algorithms to identify patients with obstructive sleep apnea (OSA): Feasibility project". Protocol ID: 20170591-01H (AMENDMENT APPROVED on December 19, 2018) to be used for future clinical, research, educational and quality improvement purposes.

Conditions

Polysomnography; Sleep Apnea Syndromes; Risk Factors; Prognosis; Restless Legs Syndrome; Periodic Limb Movement Sleep Disorder; Sleep Arousal Disorders; Opioid Use

Keywords

Sleep disorders; Health outcomes; Predictive model; Health care utilization; Validation

Outcome Measures

Primary Outcomes (1)

• Long-term adverse health consequences

  The primary outcome will be time from the index date (diagnostic sleep study) to the composite outcome of interest which include: cardio-vascular diseases, diabetes, depression, dementia, and cancer as well as chronic lung diseases and all-cause mortality. Conditions of interested will be defined from provincial health administrative data using validated algorithms that have utilized ICD-9 and ICD-10 codes as well as billing codes for outpatients visits, and procedural codes. Please see ICES Data Dictionary for details: https://www.ices.on.ca/Data-and-Privacy/ICES-data/Data-dictionary.

  Through study completion, up to 10 years

Secondary Outcomes (2)

• Health care utilization

  Through study completion, up to 10 years

• Motor vehicle crashes

  Through study completion, up to 10 years

Interventions

No intervention but exposure OTHER

Different sleep disorders will be considered as an exposure. The data elements included in the database: demographics, date of the sleep study, study type, all available polysomnography indices, symptoms, sleep schedule, comorbidities, medications, social history, electrocardiography, positive airway pressure treatment related variables.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Please see above

You may qualify if:

• All adults who underwent a diagnostic sleep study in the TOH Sleep Center from Apr 2015 to April 2017

You may not qualify if:

• Uninsured individuals
• Individuals who did not agree for their data to be linked to the ICES
• Individuals who underwent split-night sleep studies

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Ottawa: collaborator
• University of Toronto: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, 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; Restless Legs Syndrome; Sleep Arousal Disorders; Sleep Wake Disorders; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Tetyana Kendzerska, MD, PhD

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: December 30, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

CA (1)