Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ana C. Krieger, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00859950
First received: March 10, 2009
Last updated: December 29, 2015
Last verified: December 2015
  Purpose
Sleep apnea is a common sleep disorder characterized by temporary stops in breathing during sleep and has been associated with the development of cardiovascular disease. This research will investigate one potential mechanism leading to the development of cardiovascular disorder, specifically, the blockage of blood vessels called "vascular occlusion", in subjects with sleep apnea. A group of healthy controls will be used for comparison. All subjects will undergo clinical evaluation followed by an overnight sleep study and a morning blood draw. Subjects with sleep apnea will be treated according to standard clinical management and followed under the research protocol for one month. At the end of one month, a repeat blood draw will be performed on the sleep apnea subjects for comparative analysis. If a control subject is found to have any abnormality during this research study, he or she will be referred for further clinical evaluation.

Condition Intervention
Obstructive Sleep Apnea
Hypoxemia
Device: Continuous Positive Airway Pressure (CPAP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • NTPDase (vascular enzyme) activity in white blood cells [ Time Frame: Day 1 (all subjects) and Day 34 (post treatment - sleep apnea only) ] [ Designated as safety issue: No ]
  • Circulating endothelial cells (CECs) [ Time Frame: Day 1 (all subjects) and Day 34 (post treatment - sleep apnea only) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the effect of sleep apnea therapy in increasing vascular enzyme (NTPDase) activity and decreasing the level of circulating endothelial cells (CECs). [ Time Frame: At completion of study ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: April 2009
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sleep Apnea
Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.
Device: Continuous Positive Airway Pressure (CPAP)
Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw.
No Intervention: Normal Control
Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.

Detailed Description:

The importance of this project is to investigate mechanisms of vascular disease in sleep apnea and determine pathways for intervention, aiming to prevent the development of cardiovascular disease in these individuals.

This proposed research aims to evaluate both NTPDase activity in lymphocytes and levels of circulating endothelial cells (CECs) in patients with intermittent hypoxemia (IH) due to obstructive sleep apnea (OSA) and healthy controls. This is an original approach to define mechanisms which underlie the high incidence of occlusive vascular events in patients with OSA. The evaluation of such pathophysiological mechanisms will lead to a better understanding of the pathways involved and the development of therapeutic strategies targeting the reduction or avoidance of endothelial injury with the ultimate goal of reducing morbidity and mortality associated with these pathologic events in sleep apnea. The standard of care will be used in this protocol, which involves the use of CPAP (continuous positive airway pressure) for treating sleep apnea.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Study Group 1: Sleep Apnea

Inclusion Criteria:

  • 21 years or older
  • Presence of intermittent hypoxemia (IH) and obstructive sleep apnea (OSA)
  • No diagnosis of hypertension, coronary artery disease, diabetes, stroke, or evidence of underlying vascular disease

Exclusion Criteria:

  • Smoking
  • Pregnancy
  • Known cardiovascular disease, stroke, or diabetes
  • Current or previous treatment for sleep apnea
  • Central or Cheyne-Stokes sleep apnea
  • Use of supplemental oxygen at night
  • Alcohol abuse
  • Regular use of sedatives
  • Regular use of aspirin or cholesterol lowering agents

Study Group 2: Normal Controls

Inclusion Criteria:

  • 21 years or older
  • No diagnosis of intermittent hypoxemia (IH) or obstructive sleep apnea (OSA)
  • No diagnosis of hypertension, coronary artery disease, diabetes, stroke, or evidence of underlying vascular disease

Exclusion Criteria:

  • Smoking
  • Pregnancy
  • Known cardiovascular disease, stroke, or diabetes
  • Use of supplemental oxygen at night
  • Alcohol abuse
  • Regular use of sedatives
  • Regular use of aspirin or cholesterol lowering agents
  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: NCT00859950

Locations
United States, New York
Weill Cornell Medical College - Weill Cornell Pulmonary Associates
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Ana C Krieger, MD, MPH Weill Medical College of Cornell University
  More Information

Responsible Party: Ana C. Krieger, Dr. Ana Krieger, MD. MPH, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00859950     History of Changes
Other Study ID Numbers: 0811010102  1K23HL094358-01A2 
Study First Received: March 10, 2009
Last Updated: December 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Sleep Apnea
Vascular Occlusion
Nocturnal Polysomnography
Continuous Positive Airway Pressure

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

ClinicalTrials.gov processed this record on September 27, 2016