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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Hospital Miguel Servet.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Miguel Servet
ClinicalTrials.gov Identifier:
NCT01175421
First received: August 3, 2010
Last updated: July 7, 2011
Last verified: August 2010
  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:


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 ]

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
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 Recruiting
Zaragoza, Spain, 50190
Contact: José M Marin, M.D.       jmmarint@unizar.es   
Sponsors and Collaborators
Hospital Miguel Servet
Investigators
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
Sleep Apnea, Obstructive
Snoring
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 September 30, 2014