N/A
N=153
Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea
Sleep Apnea Syndromes · Oxidative Stress · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00607893 ↗Enrolled (actual)
153
Serious AEs
3.1%
Results posted
Sep 2017
Primary outcome: Primary: F2-isoprostanes/Cr — -0.02; -0.08 ng/mg — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Positive Airway Pressure (CPAP) (Device); Sham CPAP (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY F2-isoprostanes/Cr |
-0.02; -0.08 | 0.38 |
| PRIMARY Myeloperoxidase |
-3.33; -5.15 | 0.85 |
| SECONDARY Mean Arterial BP, Evening |
-0.59; -0.72 | 0.92 |
| SECONDARY Pulse Wave Velocity, Evening |
-0.08; -0.30 | 0.55 |
| SECONDARY IL-6 |
0.29; -0.08 | 0.17 |
| SECONDARY Mean Arterial BP, Morning |
0.24; -2.17 | 0.076 |
| SECONDARY sIL-6R |
0.02; -0.04 | 0.019 sig |
| SECONDARY Pulse Wave Velocity, Morning |
-0.25; -0.42 | 0.68 |
| SECONDARY Augmentation Index, Evening |
-0.43; -1.79 | 0.59 |
| SECONDARY Augmentation Index, Morning |
0.44; -6.49 | <0.001 sig |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00607893). 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.