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

U

University Hospital Miguel Servet

Status

Completed

Conditions

Snoring
Sleep Apnea

Study type

Observational

Funder types

Other

Identifiers

NCT01175421
PS09/02449

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults patients (> 18 years)

Exclusion criteria

  • Under 18 years old
  • Unable to complete sleep study

Trial design

1,100 participants in 1 patient group

Patients undergoing sleep study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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