An interventional study of Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea and Hypoxemia, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Basic science
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 70 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study Group 1: Sleep Apnea
Inclusion Criteria:
Exclusion Criteria:
Study Group 2: Normal Controls
Inclusion Criteria:
Exclusion Criteria:
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)
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.
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.
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)
| Milestone | Sleep Apnea | Normal Control |
|---|---|---|
| Started | 49 | 21 |
| Completed | 49 | 21 |
| Not completed | 0 | 0 |
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.
| events/hour | Sleep Apnea | Normal Control |
|---|---|---|
| ODI | 24.71 ± 30.15 | .97 ± 1.43 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Control | — | 0/21 (0%) | 0/21 (0%) |
| Sleep Apnea | — | 0/49 (0%) | 0/49 (0%) |
| Age, Categorical(Participants) | Sleep Apnea | Normal Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 47 | 21 | 68 |
| >=65 years | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | Sleep Apnea | Normal Control | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 43 | 15 | 58 |
Plan to share: No
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Weill Medical College of Cornell University