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

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ClinicalTrials.gov Identifier: NCT01175421
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Jose M. Marin, Hospital Miguel Servet

August 3, 2010
August 4, 2010
March 23, 2015
May 2010
May 2013   (Final data collection date for primary outcome measure)
All cause mortality [ Time Frame: Five years ]
Same as current
Complete list of historical versions of study NCT01175421 on ClinicalTrials.gov Archive Site
Cardiovascular events [ Time Frame: Five years ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Sleep Clinic
  • Snoring
  • Sleep Apnea
Not Provided
Patients undergoing sleep study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
Same as current
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults patients (> 18 years)

Exclusion Criteria:

  • Under 18 years old
  • Unable to complete sleep study
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01175421
PS09/02449
No
Not Provided
Not Provided
Jose M. Marin, Hospital Miguel Servet
Hospital Miguel Servet
Not Provided
Principal Investigator: Jose M Marin, M.D. Hospital Universitario Miguel Servet
Hospital Miguel Servet
August 2010