View Clinical Trial (Medical Research Study)
Sleep Apnea in Cerebrovascular Disease - NCT00807417-06516(Clinical Trial 259083)
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| City: |
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West Haven |
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State:
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CT |
| Zip Code: |
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06516 |
| Conditions: |
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Cerebrovascular Stroke - Transient Ischemic Attack - Sleep Apnea - Blood Pressure, High |
| Purpose: |
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This study seeks to evaluate a diagnostic and therapeutic intervention strategy among
veterans with cerebrovascular disease, hypertension and obesity that consists of using
unattended sleep studies to diagnose sleep apnea and CPAP to treat sleep apnea. It is
hypothesized that the intervention strategy will (1) reduce hypertension at the end of the
one-year study period, (2)reduce daytime sleepiness, (3)result in improved cognitive
function, (4) result in improved quality of life and(4) will increase the rate and treatment
of diagnosed sleep apnea.
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| Study summary: |
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The study will evaluate a diagnostic/therapeutic intervention among veterans with
cerebrovascular disease, hypertension, and obesity using unattended polysomnography to
diagnose sleep apnea and CPAP with an adherence/educational protocol to treat sleep apnea.
Electronic databases will be used to identify patients at two VA medical centers with
cerebrovascular disease (stroke or Transient Ischemic Attack (TIA)) who have hypertension
and obesity. The patients will be randomly assigned to the intervention arm (N=167) or the
control (usual care) arm (N=167). Patients in the intervention arm who have sleep apnea will
receive auto-titrating CPAP therapy for one year. Control patients will receive usual care
and their primary care providers will be notified that they are at risk for having sleep
apnea; control patients will receive unattended polysomnography at the end of the one-year
study period.Twenty-four hour blood pressure will be measured in both groups at baseline and
after one year. |
| Criteria: |
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Inclusion Criteria:
1. History of ischemic stroke or Transient Ischemic Attack (TIA)
2. Diagnosis of hypertension or blood pressure 140/90 or greater
3. Body Mass Index 30kg/m or greater
Exclusion Criteria:
1. Known sleep apnea -
2. Suspected sleep disorder other than sleep apnea (e.g. narcolepsy)
3. Life expectancy is less than six months
4. Patients unable to use either a nasal or face mask (e.g. facial trauma)
5. Non-English language patients
6. Inability to provide informed consent (proxy consents will not be accepted). |
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| Study is available at: |
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West Haven VA Medical Center
West Haven, CT 06516
United States
Primary Contact:
Henry K Yaggi, M.D., MPH
Email: henry.yaggi@yale.edu
Phone: 203-932-5711
Secondary Contact:
Dawn M. Bravata, M.D.
Email: dbravata@iupui.edu
Phone: 317 988 2676 |
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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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