Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Brief Summary

Official Title: “Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease”

Sleep apnea is common among veterans with cerebrovascular disease (stroke or transient ischemic attack [TIA]), leads to hypertension, and is associated with recurrent stroke and death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: September 2011

Detailed Clinical Trial Description

The project seeks to evaluate whether a diagnostic and therapeutic intervention strategy among veterans with cerebrovascular disease and hypertension using unattended polysomnography and auto-titrating CPAP with a targeted adherence evaluation and educational protocol results in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and lowered mean 24-hour systolic blood pressure. Secondary aims include: to determine whether the intervention strategy reduces the number of antihypertensive medications; to collect data supporting a cost-effectiveness evaluation if the intervention strategy is effective; and to determine whether the intervention strategy reduces daytime sleepiness.

Interventions Used in this Clinical Trial

  • Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
    • Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1
    • The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
  • Other: Arm 2
    • The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services

Outcome Measures for this Clinical Trial

Primary Measures

  • Sleep apnea diagnosis rate
    • Time Frame: One year
      Safety Issue?: No

Secondary Measures

  • Sleep apnea treatment rate
    • Time Frame: One year
      Safety Issue?: No
  • Rate of sleep apnea treatment
    • Time Frame: One year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

Stroke or Transient Ischemic Attack Hypertension

Exclusion Criteria

  • Prior diagnosis of sleep apnea or other sleep disorder
  • Life expectancy < 6 months or Hospice
  • Non-English speaker
  • Unable/unwilling to use mask
  • Inability to give informed consent
  • Oxygen dependent COPD
  • Chronic renal failure with dialysis
  • Active Suicidal Ideation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Department of Veterans Affairs
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dawn M. Bravata, MD, Principal Investigator, Richard Roudebush VA Medical Center, Indianapolis

Citations Reporting on Results

Sico JJ, Phipps MS, Yaggi HK, Burrus N, Ferguson J, McClain V, Austin C, Li X, Bravata DM. Ambulatory blood pressure monitoring among patients with cerebrovascular disease. Blood Press Monit. 2011 Oct;16(5):211-7. doi: 10.1097/MBP.0b013e32834b4d6c. Review.

Bravata DM, Concato J, Fried T, Ranjbar N, Sadarangani T, McClain V, Struve F, Zygmunt L, Knight HJ, Lo A, Richerson GB, Gorman M, Williams LS, Brass LM, Agostini J, Mohsenin V, Roux F, Yaggi HK. Continuous positive airway pressure: evaluation of a novel therapy for patients with acute ischemic stroke. Sleep. 2011 Sep 1;34(9):1271-7. doi: 10.5665/SLEEP.1254.

Mokhlesi B, Pamidi S, Yaggi HK. Sleep disordered breathing and subjective sleepiness in the elderly: a deadly combination? Sleep. 2011 Apr 1;34(4):413-5.

Vaz Fragoso CA, Gill TM, McAvay G, Van Ness PH, Yaggi HK, Concato J. Use of lambda-mu-sigma-derived Z score for evaluating respiratory impairment in middle-aged persons. Respir Care. 2011 Nov;56(11):1771-7. doi: 10.4187/respcare.01192. Epub 2011 May 20.

Haggstrom DA, Saleem JJ, Russ AL, Jones J, Russell SA, Chumbler NR. Lessons learned from usability testing of the VA's personal health record. J Am Med Inform Assoc. 2011 Dec;18 Suppl 1:i13-7. doi: 10.1136/amiajnl-2010-000082. Epub 2011 Oct 8.

French DD, Bradham DD, Campbell RR, Haggstrom DA, Myers LJ, Chumbler NR, Hagan MP. Factors associated with program utilization of radiation therapy treatment for VHA and medicare dually enrolled patients. J Community Health. 2012 Aug;37(4):882-7. doi: 10.1007/s10900-011-9523-y.

Bravata DM, Ferguson J, Miech EJ, Agarwal R, McClain V, Austin C, Struve F, Foresman B, Li X, Wang Z, Williams LS, Dallas MI, Couch CD, Sico J, Fragoso C, Matthias MS, Chumbler N, Myers J, Burrus N, Dube A, French DD, Schmid AA, Concato J, Yaggi HK. Diagnosis and Treatment of Sleep Apnea in patients' homes: the rationale and methods of the "GoToSleep" randomized-controlled trial. J Clin Sleep Med. 2012 Feb 15;8(1):27-35.

Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics–2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. Erratum in: Circulation. 2012 Jun 5;125(22):e1002.

Salyers MP, Matthias MS, Fukui S, Holter MC, Collins L, Rose N, Thompson JB, Coffman MA, Torrey WC. A coding system to measure elements of shared decision making during psychiatric visits. Psychiatr Serv. 2012 Aug;63(8):779-84. doi: 10.1176/appi.ps.201100496.

Yu Z, Liu L, Bravata DM, Williams LS, Tepper RS. A semiparametric recurrent events model with time-varying coefficients. Stat Med. 2013 Mar 15;32(6):1016-26. doi: 10.1002/sim.5575. Epub 2012 Aug 18.

Williams LS. Patient-reported outcomes: progress toward speaking the patient's language. Neurology. 2012 Jun 5;78(23):1813-4. doi: 10.1212/WNL.0b013e318258f878. Epub 2012 May 9.

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics–2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. Review.

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics–2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. Review. Erratum in: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad.

Chumbler NR, Haggstrom D, Saleem JJ. Implementation of health information technology in Veterans Health Administration to support transformational change: telehealth and personal health records. Med Care. 2011 Dec;49 Suppl:S36-42. doi: 10.1097/MLR.0b013e3181d558f9.

Bravata DM, Concato J, Fried T, Ranjbar N, Sadarangani T, McClain V, Struve F, Zygmunt L, Knight HJ, Lo A, Richerson GB, Gorman M, Williams LS, Brass LM, Agostini J, Mohsenin V, Roux F, Yaggi HK. Auto-titrating continuous positive airway pressure for patients with acute transient ischemic attack: a randomized feasibility trial. Stroke. 2010 Jul;41(7):1464-70. doi: 10.1161/STROKEAHA.109.566745. Epub 2010 May 27.

Botros N, Concato J, Mohsenin V, Selim B, Doctor K, Yaggi HK. Obstructive sleep apnea as a risk factor for type 2 diabetes. Am J Med. 2009 Dec;122(12):1122-7.

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00984308