Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
In a retrospective cohort the investigators will validate, the goodness of a multidimensional index to classified the severity of patients with sleep disordered breathing that has been previously developed in a prospective longitudinal cohort.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Development and Validation of a Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE|
- All cause mortality [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
- Cardiovascular events [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Patients undergoing sleep study|
Methods. In the developing study, three variables were found as predictors of mayor outcomes and were incorporated in a multidimensional index: the apnea-hypopnea index, the severity of daytime sleepiness as quantified by the Epworth questionnaire and the presence of current cardiovascular disease. The index (OSA-SCORE) has a value between 0 (less risk) to 5 (more risk). For each point, a significant increment in the risk of death was found. In the retrospective validation study, a number of potential variables will be recorded, all of them also predictors of major outcomes. Data will be recorded by trained personnel on-site at the respiratory Sleep Units around the country. The final cohort will include 1100 subjects aged > 18 years . The observation time will be considered since the time at diagnosis to fatal event and the patient will be censored when non-invasive ventilation was started or at the recorded time if the patient is alive. The primary outcome is all-cause death.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175421
|Hospital Universitario Miguel Servet|
|Zaragoza, Spain, 50190|
|Principal Investigator:||Jose M Marin, M.D.||Hospital Universitario Miguel Servet|