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Right Ventricular Function in Obstructive Sleep Apnea

This study has been completed.

Sponsored by: Florence Nightingale Hospital, Istanbul
Information provided by: Florence Nightingale Hospital, Istanbul
ClinicalTrials.gov Identifier: NCT00640536
  Purpose

The purpose of this study is to determine the structural and functional cardiac alterations in obstructive sleep apne (OSA) independent from systemic hypertension and their correlation to the severity of OSA.


Condition
Sleep Apnea, Obstructive

MedlinePlus related topics:   High Blood Pressure    Sleep Apnea   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   The Evaluation of Right Ventricular Systolic and Diastolic Function in Patients With Newly Diagnosed Obstructive Sleep Apnea Syndrome Without Hypertension

Further study details as provided by Florence Nightingale Hospital, Istanbul:

Enrollment:   71
Study Start Date:   January 2006
Study Completion Date:   March 2008
Primary Completion Date:   March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
Newly diagnosed obstructive sleep apnea patients without hypertension
2
Age, sex and and body mass index-matched matched healthy subjects

Detailed Description:

Many risk factors for OSA, such as male gender, obesity, and increasing age are the same as for cardiovascular diseases. This fact makes it more difficult to establish a causal relationship between OSA and cardiovascular diseases. The relationship between OSA and right ventricular (RV) function is controversial. RV dysfunction may be a result of chronic intermittent hypoxia and hypercapnia during apneic episodes. It may also occur secondary to left ventricular dysfunction as a result of increased afterload and sympathetic activity which causes secondary hypertension. As systemic hypertension is one of the most accompanying and contributing factors in OSA along with obesity, we tried to compare the effects of newly diagnosed OSA on RV function with an age and body mass index- matched control group.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample

Study Population

Tertiary care clinic, obstructive sleep apnea patients


Criteria

Inclusion Criteria:

For OSA patients (group1)

  • Apnea Hypopnea Index equal or more than 15
  • Epworth sleepiness scale equal or more than 10
  • No previous treatment for OSA

Exclusion Criteria:

  • Age < 18 years
  • Known hypertension, or 24-hour mean blood pressure of 135 and/or 85 mmHg or more
  • Diabetes mellitus
  • Left ventricular ejection fraction < 60%
  • Moderate to severe valvular disease
  • Cardiomyopathy
  • Renal failure
  • Coronary artery disease
  • Obstructive or restrictive lung disease demonstrated on pulmonary function test
  • Connective-tissue or chronic thromboembolic disease
  • Pericardial disease
  • Cancer and/or other important comorbidities with an expected survival < 2 years
  • Suboptimal echocardiographic images for measurements
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640536

Locations
Turkey, Caglayan
Florence Nightingale Hospital    
      Istanbul, Caglayan, Turkey, 34381

Sponsors and Collaborators
Florence Nightingale Hospital, Istanbul

Investigators
Principal Investigator:     Saide Aytekin     T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology    
  More Information


Publications:

Responsible Party:   T.C. Istanbul Bilim University; Florence Nightingale Hospital ( Prof. Dr. Saide Aytekin )
Study ID Numbers:   AT-1974/1
First Received:   March 17, 2008
Last Updated:   March 20, 2008
ClinicalTrials.gov Identifier:   NCT00640536
Health Authority:   Turkey: Ministry of Health;   Turkey: Ethics Committee

Study placed in the following topic categories:
Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Hypertension

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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