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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

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Patients undergoing sleep study


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. All cause mortality [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. Cardiovascular events [ Time Frame: Five years ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sleep Clinic
Criteria

Inclusion Criteria:

  • Adults patients (> 18 years)

Exclusion Criteria:

  • Under 18 years old
  • Unable to complete sleep study
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175421


Locations
Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50190
Sponsors and Collaborators
Hospital Miguel Servet
Investigators
Principal Investigator: Jose M Marin, M.D. Hospital Universitario Miguel Servet
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jose M. Marin, M.D., Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT01175421     History of Changes
Other Study ID Numbers: PS09/02449
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: August 2010

Keywords provided by Jose M. Marin, Hospital Miguel Servet:
snoring
sleep apnea
sleep study
cardiovascular outcomes

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Snoring
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds