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Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea, Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea focused on measuring Sleep Apnea, Vascular Occlusion, Nocturnal Polysomnography, Continuous Positive Airway Pressure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weill Cornell Medical College - Weill Cornell Pulmonary Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sleep Apnea

Normal Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2009
Last Updated
January 16, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00859950
Brief Title
Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea
Official Title
Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypoxemia
Keywords
Sleep Apnea, Vascular Occlusion, Nocturnal Polysomnography, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Apnea
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
ODI
Description
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.
Time Frame
Day 1 (all subjects)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana C Krieger, MD, MPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College - Weill Cornell Pulmonary Associates
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32036486
Citation
Krieger AC, Anand R, Hernandez-Rosa E, Maidman A, Milrad S, DeGrazia MQ, Choi AJ, Oromendia C, Marcus AJ, Drosopoulos JHF. Increased platelet activation in sleep apnea subjects with intermittent hypoxemia. Sleep Breath. 2020 Dec;24(4):1537-1547. doi: 10.1007/s11325-020-02021-4. Epub 2020 Feb 8.
Results Reference
derived

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Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

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