N/A N=70 Basic Science

Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

Obstructive Sleep Apnea · Hypoxemia

Bottom Line

View on ClinicalTrials.gov: NCT00859950 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: ODI — 24.71; .97 events/hour

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Continuous Positive Airway Pressure (CPAP) (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY ODI	24.71; .97	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00859950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.