NCT03834792

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,155 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	No intervention but exposure	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.

Timeline

• Start date: 2018-12-30
• Primary completion: 2025-12-01
• Completion: 2028-12-01
• First posted: 2019-02-08
• Last updated: 2020-11-25

Locations

1 site across 1 country: Canada