Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
- Conditions
- Sleep ApneaSnoring
- Registration Number
- NCT01175421
- Lead Sponsor
- Hospital Miguel Servet
- Brief Summary
Purpose:
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
- Adults patients (> 18 years)
- Under 18 years old
- Unable to complete sleep study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All cause mortality Five years
- Secondary Outcome Measures
Name Time Method Cardiovascular events Five years
Trial Locations
- Locations (1)
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain