Regulation of Vascular Thrombosis in Sleep Apnea

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00859690

Collaborator

Robert Wood Johnson Foundation (Other)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea

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).

Study Design

Study Type:

Observational

Actual Enrollment :

14 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

Regulation of Vascular Thrombosis in Sleep Apnea

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

ADA gene sequence [Determined after outpatient blood draw]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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