The Role of Oxidative Stress in the Cardiovascular Consequences of Sleep Apnea

NCT00701441 | Completed Results

• 1 other identifier: 2005H0221
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive Sleep Apnea (OSA) is the most common sleep disorder affecting up to 9-24 percent of middle aged adults, and is becoming increasingly implicated in the pathogenesis of hypertension, and other cardiovascular disorders. Up to half of patients with OSA have hypertension, and their risk of developing hypertension increases with the increasing severity of Sleep Apnea. Patients with OSA and no hypertension have endothelial dysfunction, which is believed to be the precursor for most cardiovascular disorders. The upper airway collapse and obstruction that occur in OSA result in a pattern of intermittent hypoxia, that has been shown to be the cause of the hypertension, and endothelial dysfunction found in patients with OSA. Intermittent hypoxia results in oxidative stress, which in turn is linked to the pathogenesis of hypertension and endothelial dysfunction. This protocol evaluates the role of the oxidative stress in endothelial function and blood pressure in patients with OSA. This is a pilot clinical study that will compare oxidative stress parameters, and endothelial function in patients with OSA before starting treatment with continuous positive airway pressure (CPAP) and 12 weeks post being on CPAP. These patients will be compared to control patients with no history of OSA. the study does not involve assignement to different treatments. All patients will receive the indicated treatment for OSA and measurements will be collected before and 12 weeks after adequate treatment.

Conditions

Sleep Apnea

Keywords

sleep apnea,; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilation

  A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.

  Baseline and 12 weeks

Other Outcomes (1)

• Peroxynitrite Deposition in the Vascular Walls

  baseline and 12 weeks

Study Arms (2)

Control group: healthy individuals without OSA

healthy individuals without OSA who are matched in weight and age to the participating OSA patients

OSA group

Patients in the OSA group receive CPAP for 12 weeks as part of their care. patients with OSA provide measures at baseline and after 12 weeks of CPAP treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People screened for sleep apnea with a completed sleep study who do not have hypertension or coronary artery disease.

You may qualify if:

• Completed sleep study - Older than 18

You may not qualify if:

• Hypertension
• Diabetes
• coronary disease
• Peripheral vascular disease
• High cholesterol
• Smoking
• Pregnancy
• Use of erectile dysfunction medications or supplements

Sponsors & Collaborators

• Rami Khayat: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43212, United States

Location

Related Publications (1)

• Patt BT, Jarjoura D, Haddad DN, Sen CK, Roy S, Flavahan NA, Khayat RN. Endothelial dysfunction in the microcirculation of patients with obstructive sleep apnea. Am J Respir Crit Care Med. 2010 Dec 15;182(12):1540-5. doi: 10.1164/rccm.201002-0162OC. Epub 2010 Jul 23.

  PMID: 20656942 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue biopsy

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Small Feasibility trial only.

Results Point of Contact

• Title: Rami Khayat
• Organization: Ohio State University

rami.khayat@osumc.edu

614-247-7707

Study Officials

• Rami Khayat, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: June 19, 2008
• Study Start: February 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 30, 2013
• Results First Posted: October 30, 2013

Record last verified: 2013-10

Locations

US (1)