| September 24, 2009 |
| April 18, 2013 |
| December 2008 |
| September 2011 (final data collection date for primary outcome measure) |
| Sleep apnea diagnosis rate [ Time Frame: One year ] [ Designated as safety issue: No ] |
| Blood pressure [ Time Frame: One year ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00984308 on ClinicalTrials.gov Archive Site |
- Sleep apnea treatment rate [ Time Frame: One year ] [ Designated as safety issue: No ]
- Rate of sleep apnea treatment [ Time Frame: One year ] [ Designated as safety issue: No ]
|
| Not Provided |
| Not Provided |
| Not Provided |
| |
| Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease |
| 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. |
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. |
| Interventional |
Phase 2
Phase 3 |
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment |
- Obstructive Sleep Apnea
- Stroke
- Transient Ischemic Attack
- Hypertension
|
| 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. |
- Experimental: Arm 1
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
Intervention: Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
- Arm 2
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
Intervention: Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
|
- 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. 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Cheng EM, Bravata DM, El-Saden S, Vassar SD, Ofner S, Williams LS, Keyhani S. Carotid Artery Stenosis: Wide Variability in Reporting Formats--A Review of 127 Veterans Affairs Medical Centers. Radiology. 2013 Jan;266(1):289-294. Epub 2012 Nov 9.
- 1. Error occurred: cannot get document summary PMID: 22968111
- 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.
- 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. Epub 2011 Dec 15. Erratum in: Circulation. 2012 Jun 5;125(22):e1002.
|
| |
| Completed |
| 225 |
| September 2011 |
| September 2011 (final data collection date for primary outcome measure) |
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
|
| Both |
| 40 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00984308 |
| IIR 06-233 |
| No |
| Department of Veterans Affairs |
| Department of Veterans Affairs |
| Not Provided
| Principal Investigator: |
Dawn M. Bravata, MD |
Richard Roudebush VA Medical Center, Indianapolis |
|
|
| Department of Veterans Affairs |
| March 2012 |
