Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea (SASS)
|Sleep Apnea Syndromes Oxidative Stress Cardiovascular Diseases||Device: Continuous Positive Airway Pressure (CPAP) Device: Sham CPAP|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oxidative Stress in Sleep Apnea and Cardiac Disease|
- Oxidative stress [ Time Frame: Measured between Months 2 and 3 of treatment ]
- Blood pressure [ Time Frame: Measured between Months 2 and 3 of treatment ]
- Pulse wave analysis [ Time Frame: Measured between Months 2 and 3 of treatment ]
- Measures of inflammation [ Time Frame: Measured between Months 2 and 3 of treatment ]
- Salivary cortisol [ Time Frame: Measured between Months 2 and 3 of treatment ]
- Insulin resistance [ Time Frame: Measured between Months 2 and 3 of treatment ]
|Study Start Date:||September 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Sham Comparator: 1
Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.
Device: Sham CPAP
Participants will use the lower pressure CPAP every night for 8 weeks.
Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.
Device: Continuous Positive Airway Pressure (CPAP)
Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
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 daytime drowsiness, impaired mental functioning, and trouble concentrating or staying alert. SDB is also associated with an increased risk of certain cardiovascular diseases, such as high blood pressure and heart disease. Researchers believe that increased oxidative stress and inflammation associated with SDB may play a role in the physiologic pathway linking SDB and CVD. However, more information on the SDB-CVD relationship is needed to be able to identify risk factors for CVD and to discover the best means of treatment. CPAP, a current treatment for SDB, acts by delivering air through a mask during sleep. CPAP helps improve overnight breathing and quality of sleep and may, in turn, decrease oxidative stress and associated CVD risks. This study will compare the effectiveness of CPAP versus placebo CPAP in reducing CVD risk factors, such as oxidative stress markers, in people with SDB.
Participation in this study will last between 2.5 and 4 months and will include four to five study visits. During the first study visit, participants will undergo a CPAP titration study, which will involve appropriate CPAP mask fitting and an overnight sleep test to determine the best CPAP pressure, as well as a lower placebo pressure, for each participant. Participants will also be provided educational information on diet, sleep, and the use of CPAP as a treatment for sleep apnea. After the titration study, participants will be asked to wear their fitted CPAP mask every night for the next 2 weeks, during which they will use the lower (placebo) pressure one week and use the higher pressure the other week. During this time, a technician will contact participants every 3 to 4 days to address any questions or problems with the CPAP equipment.
One month later, participants who were able to tolerate and use CPAP most nights will attend Visit 2. This second visit will include an overnight sleep study without wearing the CPAP mask; blood and saliva collection; cheek brushing for genetic material; tests on diabetes, artery stiffness, and circulation; body fat measurements; and questionnaires. Participants will then be randomly assigned to use either the higher pressure CPAP or the lower pressure CPAP for 8 weeks. Visit 3 will occur 1 week after beginning CPAP treatment and will include a fasting blood test. During treatment, participants will be periodically contacted by a technician to check on equipment status.
Upon completing treatment, participants will undergo repeat tests from Visit 2, except that they will wear the CPAP mask in the overnight sleep test. This fourth study visit will mark the completion of treatment for participants assigned to the lower pressure CPAP. Participants assigned to the higher pressure CPAP will be asked to use CPAP for 4 more weeks. These participants will return at the end of the 4 weeks for a final visit, which will include a repeat sleep study and other testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607893
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Reena Mehra, MD, MS||University Hospitals Cleveland Medical Center|