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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Reena Mehra, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00607893
First received: January 25, 2008
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Sleep Apnea Syndromes
Oxidative Stress
Cardiovascular Diseases
Device: Continuous Positive Airway Pressure (CPAP)
Device: Sham CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxidative Stress in Sleep Apnea and Cardiac Disease

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Oxidative stress [ Time Frame: Measured between Months 2 and 3 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Measured between Months 2 and 3 of treatment ] [ Designated as safety issue: No ]
  • Pulse wave analysis [ Time Frame: Measured between Months 2 and 3 of treatment ] [ Designated as safety issue: No ]
  • Measures of inflammation [ Time Frame: Measured between Months 2 and 3 of treatment ] [ Designated as safety issue: No ]
  • Salivary cortisol [ Time Frame: Measured between Months 2 and 3 of treatment ] [ Designated as safety issue: No ]
  • Insulin resistance [ Time Frame: Measured between Months 2 and 3 of treatment ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: September 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 2
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.

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 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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Moderate to severe 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607893

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Reena Mehra, MD, MS University Hospital Case Medical Center
  More Information

Publications:
Responsible Party: Reena Mehra, Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00607893     History of Changes
Other Study ID Numbers: 562, K23HL079114
Study First Received: January 25, 2008
Last Updated: July 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Case Western Reserve University:
Sleep-Disordered Breathing

Additional relevant MeSH terms:
Cardiovascular Diseases
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014