CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Continuous Positive Airway Pressure (CPAP)device
Likely dose
Continuous positive airway pressure (CPAP) - standard clinical therapy for OSAAI-extracted
Key inclusion· 4
  • Age 21 years or older
  • Presence of intermittent hypoxemia (IH) and obstructive sleep apnea (OSA) [Study Group 1 only]
  • No prior diagnosis of hypertension, coronary artery disease, diabetes, stroke, or underlying vascular disease
  • No diagnosis of IH or OSA [Study Group 2 - Normal Controls only]
Key exclusion· 9
  • Current or prior smoking history
  • Current or prior treatment for sleep apnea [Study Group 1]
  • Known cardiovascular disease, stroke, or diabetes
  • Central or Cheyne-Stokes sleep apnea [Study Group 1]

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00859950
NCT00859950N/ACompleted

Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

Weill Medical College of Cornell University·interventional·Posted Mar 11, 2009·Updated Feb 4, 2019

In Brief

A clinical study evaluating Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea and Hypoxemia. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2009
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.3 years ago

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.