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

This study has been completed.
Information provided by (Responsible Party):
Jose M. Marin, Hospital Miguel Servet Identifier:
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.

Sleep Apnea

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Hospital Miguel Servet:

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 ]

Enrollment: 1100
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

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.

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sleep Clinic

Inclusion Criteria:

  • Adults patients (> 18 years)

Exclusion Criteria:

  • Under 18 years old
  • Unable to complete sleep study
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Please refer to this study by its identifier: NCT01175421

Hospital Universitario Miguel Servet
Zaragoza, Spain, 50190
Sponsors and Collaborators
Hospital Miguel Servet
Principal Investigator: Jose M Marin, M.D. Hospital Universitario Miguel Servet
  More Information

Responsible Party: Jose M. Marin, M.D., Hospital Miguel Servet Identifier: NCT01175421     History of Changes
Other Study ID Numbers: PS09/02449 
Study First Received: August 3, 2010
Last Updated: March 19, 2015
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Hospital Miguel Servet:
sleep apnea
sleep study
cardiovascular outcomes

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Sounds
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on May 22, 2016