Regulation of Vascular Thrombosis in Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00859690
First received: March 10, 2009
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. A better understanding of the mechanisms associated with the development of cardiovascular disease in sleep apnea is needed.

This research will investigate the function of the adenosine deaminase (ADA) in subjects with sleep disorders. This enzyme is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances. The overall objective of this experiment is to assess the presence of ADA polymorphisms in sleep apnea.


Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Regulation of Vascular Thrombosis in Sleep Apnea

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ADA gene sequence [ Time Frame: Determined after outpatient blood draw ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

A total of 15ml (approximately 1 tablespoon) of whole blood will be collected from each subject during his or her out-patient office visit. This sample will be retained for genomic analysis


Enrollment: 14
Study Start Date: March 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sleep Disorder - Sleep Apnea
Subjects determined by a clinically indicated overnight sleep study (Nocturnal Polysomnography) to have Obstructive Sleep Apnea (OSA).
Sleep Disorder - Not Sleep Apnea
Subjects determined by a clinically indicated overnight sleep study (Nocturnal Polysomnography) to have a sleep disorder other than Obstructive Sleep Apnea (OSA).

Detailed Description:

Obstructive Sleep Apnea (OSA) is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. More specifically, OSA has been linked with thrombosis, or the formation of clots in the blood vessels which can lead to heart attack or stroke. A better understanding of the mechanisms associated with thrombosis and the development of cardiovascular disease in patients with obstructive sleep apnea is needed.

This research will investigate the function of the enzyme adenosine deaminase (ADA) in subjects with sleep disorders. ADA is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances.

A total of 60 subjects presenting for the evaluation of sleep disorders to the Weill Cornell Pulmonary Associates and the Cornell Center for Sleep Medicine practices will be offered participation in this study. The subjects with sleep apnea will be ethnically matched to the subjects with sleep disorders other than sleep apnea (controls). Once written informed consent is obtained by the Principal Investigator, venipuncture will be performed in the office by a trained phlebotomist. A total of 15 ml (approximately 1 tablespoon) of blood will be collected. The patient will be monitored for ten minutes following the blood draw to ensure adequate hemostasis. The blood samples will be utilized for DNA sequencing and determination of adenosine deaminase genotype and phenotype.

Information from clinically indicated overnight sleep studies performed within 6 months of (prior or after) the visit will be used to categorize subjects into groups (sleep apnea vs. sleep disorder other than sleep apnea).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from patients presenting for sleep disorders at the Weill Cornell Pulmonary Associates / Cornell Center for Sleep Medicine practices at New York-Presbyterian Hospital in New York City.

Criteria

Inclusion Criteria:

  • 21 years or older
  • Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices
  • Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit

Exclusion Criteria:

  • Pregnancy
  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: NCT00859690

Sponsors and Collaborators
Weill Medical College of Cornell University
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Ana C Krieger, MD, MPH Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00859690     History of Changes
Other Study ID Numbers: 0901010175, Robert Wood Johnson Foundation
Study First Received: March 10, 2009
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Obstructive Sleep Apnea
Thrombosis
Adenosine Deaminase
Sleep Disorder

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Disorders
Thrombosis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014