Status:
COMPLETED
Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Apnea Syndromes
Oxidative Stress
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
It is estimated that 18 million Americans are affected by SDB. SDB involves repeated sleep arousal caused by breathing difficulties. These frequent sleep disruptions may cause a person to experience d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00607893
Start Date
September 1 2006
End Date
July 1 2011
Last Update
September 15 2017
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106