Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

NCT00859950 | Completed Results DMC

• 2 other identifiers: 08110101021K23HL094358-01A2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Hypoxemia

Keywords

Sleep Apnea; Vascular Occlusion; Nocturnal Polysomnography; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Sleep Apnea

ACTIVE COMPARATOR

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)

Normal Control

NO INTERVENTION

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.

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

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.

Sleep Apnea

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Smoking
• Pregnancy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Weill Cornell Medical College - Weill Cornell Pulmonary Associates

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 32036486 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypoxia; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Ana Krieger
• Organization: Weill Cornell Medical College

ack2003@med.cornell.edu

646-962-7378

Study Officials

• Ana C Krieger, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ana Krieger, MD. MPH

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 4, 2019
• Results First Posted: May 17, 2017

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)