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

Study Overview

• Status: Completed
• Conditions: Snoring; Sleep Apnea

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.

• Study Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50190
    • Hospital Universitario Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sleep Clinic

Description

Inclusion Criteria:

• Adults patients (> 18 years)

Exclusion Criteria:

• Under 18 years old
• Unable to complete sleep study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing sleep study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	Five years

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular events	Five years

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet
• Investigators: Principal Investigator: Jose M Marin, M.D., Hospital Miguel Servet

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (Estimate): August 4, 2010

Study Record Updates

• Last Update Posted (Estimate): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: snoring; sleep apnea; cardiovascular outcomes; sleep study
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Respiratory Sounds; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Snoring
• Other Study ID Numbers: PS09/02449