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

Sleep Apnea Clinical Trial

— OSA-SCORE  

Official title:

Development and Validation of a Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175421
• Other study ID #: PS09/02449
• Status: Completed
• Phase: N/A
• First received: August 3, 2010
• Last updated: March 19, 2015
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: August 2010
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults patients (> 18 years)

Exclusion Criteria:

• Under 18 years old

• Unable to complete sleep study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Locations

Country	Name	City	State
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		Five years	Yes
Secondary	Cardiovascular events		Five years	Yes