Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
This study has been completed.
Information provided by (Responsible Party):
Jose M. Marin, Hospital Miguel Servet
First received: August 3, 2010
Last updated: March 19, 2015
Last verified: August 2010
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Development and Validation of a Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
Primary Outcome Measures:
- All cause mortality [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cardiovascular events [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Adults patients (> 18 years)
- Under 18 years old
- Unable to complete sleep study
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01175421
|Hospital Universitario Miguel Servet
|Zaragoza, Spain, 50190 |
Hospital Miguel Servet
||Jose M Marin, M.D.
||Hospital Universitario Miguel Servet
No publications provided
||Jose M. Marin, M.D., Hospital Miguel Servet
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 3, 2010
||March 19, 2015
||Spain: Ministry of Health and Consumption
Keywords provided by Hospital Miguel Servet:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2015
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic