Opioid Use Clinical Trial
Official title:
Adverse Long-term Consequences of Sleep Disordered Breathing: Using the Ottawa Hospital Sleep Database in Predictive Model Development and Validation.
Verified date | November 2020 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 5155 |
Est. completion date | December 2028 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion criteria: • All adults who underwent a diagnostic sleep study in the TOH Sleep Center from Apr 2015 to April 2017 Exclusion criteria: - Uninsured individuals - Individuals who did not agree for their data to be linked to the ICES - Individuals who underwent split-night sleep studies |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | University of Ottawa, University of Toronto, University of Western Ontario, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Health care utilization | All-cause mortality, all-cause hospitalizations, emergency department visits and associated costs will be defined from provincial health administrative data. Registered Persons Database will be used to define mortality. Hospitalizations and emergency department visits will be defined using: Discharge Abstract Database (all hospital admission and discharge data), National Ambulatory Care Reporting System (emergency department visits). Please see ICES Data Dictionary for details: https://www.ices.on.ca/Data-and-Privacy/ICES-data/Data-dictionary. Total healthcare expenditures will be calculated using the ICES person-level health utilization costing algorithms. | Through study completion, up to 10 years | |
Secondary | Motor vehicle crashes | Different definitions of motor vehicle crashes will be considered. Motor vehicle crashes requiring hospital or emergency department visit: the investigators will identify traffic emergencies characterized as a crash using the International Classification of Diseases codes 10th Revision (V20-V69). The investigators will include emergency department visits involving crashes in which the patient was the driver of the motor vehicle and exclude emergency department visits involving crashes in which the patient was a passenger or pedestrian. | Through study completion, up to 10 years |
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