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

NCT ID: NCT01175421

Last Updated: 2015-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Snoring Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing sleep study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults patients (\> 18 years)

Exclusion Criteria

* Under 18 years old
* Unable to complete sleep study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Miguel Servet

OTHER

Sponsor Role lead

Responsible Party

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Jose M. Marin

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose M Marin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Locations

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Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PS09/02449

Identifier Type: -

Identifier Source: org_study_id

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