Hypoxemia, Obstructive Sleep Apnea
Conditions
Keywords
Sleep Apnea, Vascular Occlusion, Nocturnal Polysomnography, Continuous Positive Airway Pressure
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.
Interventions
DEVICEContinuous 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.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ODI | Day 1 (all subjects) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sleep Apnea 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.
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. | 49 |
| Normal Control 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. | 21 |
| Total | 70 |
Baseline characteristics
| Characteristic | Sleep Apnea | Normal Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 21 Participants | 68 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 43 Participants | 15 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 49 |
| serious Total, serious adverse events | 0 / 21 | 0 / 49 |
Outcome results
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.
Time frame: Day 1 (all subjects)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Apnea | ODI | 24.71 events/hour | Standard Deviation 30.15 |
| Normal Control | ODI | .97 events/hour | Standard Deviation 1.43 |