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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jose M. Marin, Hospital Miguel Servet

ClinicalTrials.gov Identifier:

NCT01175421

First received: August 3, 2010

Last updated: March 19, 2015

Last verified: August 2010

History of Changes

Purpose

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
Snoring Sleep Apnea


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Snoring

U.S. FDA Resources

Further study details as provided by Hospital Miguel Servet:

Primary Outcome Measures:

All cause mortality [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cardiovascular events [ Time Frame: Five years ] [ Designated as safety issue: Yes ]


Enrollment:	1100
Study Start Date:	May 2010
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Patients undergoing sleep study

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Jose M. Marin, M.D., Hospital Miguel Servet
ClinicalTrials.gov Identifier:	NCT01175421 History of Changes
Other Study ID Numbers:	PS09/02449
Study First Received:	August 3, 2010
Last Updated:	March 19, 2015
Health Authority:	Spain: Ministry of Health and Consumption

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016

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