Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Apnea Syndromes, Oxidative Stress, Cardiovascular Diseases

In brief

Sleep-disordered breathing (SDB) is a condition in which a person experiences frequent breathing pauses during sleep, also known as sleep apnea. There is evidence that the recurrent sleep arousal and associated shortage of oxygen in the body may increase risk for cardiovascular disease (CVD). It is believed that treatment with continuous positive airway pressure (CPAP) may reduce certain risk factors for heart disease, including markers of inflammation and oxidative stress. This study will evaluate the effectiveness of CPAP in reducing CVD risk factors in people with SDB.

Key facts

Study ID

NCT00607893

Run by

Case Western Reserve University

People needed

153

Starts

2006-09-01

Expected to finish

2011-07-01

Last updated by the study team

2017-09-15

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Moderate to severe sleep disordered breathing (SDB) (Apnea Hypopnea Index [AHI] greater than or equal to 15) diagnosed within the 2 months before study entry
• Able to participate in more than two overnight/daytime sleep and physiologic assessments over a 2.5-month period

You may not qualify if…

• Current or planned use of specific sleep apnea treatments (e.g., CPAP, oral appliance) outside of the study
• Anticipated upper airway surgery or gastric bypass surgery in the 4 months after study completion
• Supplemental oxygen use
• Primary sleep disorder other than sleep apnea (e.g., periodic limb movement disorder)
• Severe chronic insomnia or circadian rhythm disorder with less than 4 hours of sleep per night, chronic problems falling asleep within 1 hour of bedtime, or chronic problems with early morning awakenings
• Unstable medical conditions (e.g., new onset or changing angina; heart attack or congestive heart failure exacerbation documented within the 6 months before study entry; high grade cardiac dysrhythmia/heart block; known unaddressed coronary artery disease by history, angina, stroke, or uncontrolled hypertension or diabetes mellitus; thyroid disorder; cirrhosis; a non-skin cancer diagnosed within the 2 years before study entry)
• Inadequately treated psychiatric disorders or compromised competence
• Daytime sleepiness with reports of sleepiness while driving or during other situations that would present a risk for the subject or public (e.g., operating heavy equipment)
• Alcohol abuse
• Pregnancy
• Use of oral corticosteroids

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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