Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
Recruitment status was Recruiting
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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 |
- All cause mortality [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
- Cardiovascular events [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1100 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Sleep Clinic
Inclusion Criteria:
- Adults patients (> 18 years)
Exclusion Criteria:
- Under 18 years old
- Unable to complete sleep study
Contacts and Locations| Spain | |
| Hospital Universitario Miguel Servet | Recruiting |
| Zaragoza, Spain, 50190 | |
| Contact: José M Marin, M.D. jmmarint@unizar.es | |
| Principal Investigator: | Jose M Marin, M.D. | Hospital Universitario Miguel Servet |
More Information
No publications provided
| Responsible Party: | Dr. Jose M. Marin, Hospital Universitario Miguel Servet |
| ClinicalTrials.gov Identifier: | NCT01175421 History of Changes |
| Other Study ID Numbers: | PS09/02449 |
| Study First Received: | August 3, 2010 |
| Last Updated: | July 7, 2011 |
| 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 Snoring Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Respiratory Sounds |
ClinicalTrials.gov processed this record on May 19, 2013