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Clinical Trials/NCT03834792
NCT03834792
Active, not recruiting
Not Applicable

Adverse Long-term Consequences of Sleep Disordered Breathing: Using the Ottawa Hospital Sleep Database in Predictive Model Development and Validation.

Ottawa Hospital Research Institute1 site in 1 country5,155 target enrollmentDecember 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polysomnography
Sponsor
Ottawa Hospital Research Institute
Enrollment
5155
Locations
1
Primary Endpoint
Long-term adverse health consequences
Status
Active, not recruiting
Last Updated
5 years ago

Overview

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.

Detailed Description

The primary purpose of the proposed study is to validate the previously developed predictive model by the investigators 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. From clinical and quality improvement perspective the TOH database will be used for description, evaluation, monitoring and/or educational purposes. For example, using this database the investigators will be able (i) to describe characteristics of individuals who underwent a diagnostic sleep study at the TOH between 2015 and 2017 to understand better clinical and health care utilization needs as well as to educate sleep fellows and technologists; and (ii) to evaluate the quality of the triaging process in the sleep clinic. This database will be used to: (i) examine risk factors for long-term adverse health consequences (e.g. cardio-vascular diseases, diabetes, depression, dementia, depression and cancer) among individuals referred for diagnostic sleep testing in order to identify high risk groups that are potential targets for education and treatment, (ii) develop health interventions in order to improve the quality of care and management strategies available for adults with chronic diseases that are comorbid with obstructive airway diseases and sleep-related disorders, (iii) evaluate the cost-effectiveness of the developed health interventions, e.g. screening for obstructive sleep apnea (OSA), evaluation of home versus laboratory-based diagnosis of OSA, and education strategies, (iv) develop key messages for different stakeholder groups (health care providers, patients and their relatives, provincial sleep and lung associations, public health managers, the respiratory vendor among others) related to diagnosis, education and treatment of patients with respiratory and sleep-related problems.

Registry
clinicaltrials.gov
Start Date
December 30, 2018
End Date
December 2028
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Long-term adverse health consequences

Time Frame: Through study completion, up to 10 years

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.

Secondary Outcomes

  • Health care utilization(Through study completion, up to 10 years)
  • Motor vehicle crashes(Through study completion, up to 10 years)

Study Sites (1)

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