Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859950
• Other study ID #: 0811010102
• Secondary ID: 1K23HL094358-01A
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: August 2015

Study information

• Verified date: January 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypoxemia
• Hypoxia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College - Weill Cornell Pulmonary Associates	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ODI	The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.	Day 1 (all subjects)