| City: |
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Cleveland |
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State:
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OH |
| Zip Code: |
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44106 |
| Conditions: |
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Sleep Apnea Syndromes - Oxidative Stress - Cardiovascular Diseases |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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University Hospitals Case Medical Center
Cleveland, OH 44106
United States
Primary Contact:
Sandra Stennis, BS
Email: sds76@case.edu
Phone: 216-368-0083
Secondary Contact:
Sandra Stennis, BS
Email: sds76@case.edu
Phone: 216-368-0083 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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