NCT01175421

Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE

Development and Validation of a Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (actual)
• Sponsor: Hospital Miguel Servet · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Snoring
• Sleep Apnea

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-08-04
• Last updated: 2015-03-23

Locations

1 site across 1 country: Spain