Clinical trial NCT00984308: Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Official title: Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obstructive Sleep Apnea
Stroke
Transient Ischemic Attack
Hypertension
Keywords: sleep apnea
hypertension
brain ischemia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-09-25
Enrollment: 225
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The project sought 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 resulted in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and improved blood pressure control.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep Apnea Diagnosis Rate
timeFrame: The entire study period (baseline and up to one-year)
measure: Hypertension Control
timeFrame: One year
Secondary outcomes:
measure: Sleep Apnea Treatment Rate
timeFrame: One year
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Dawn M. Bravata, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
citation: 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. No abstract available.
citation: 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. No abstract available.
citation: 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.
citation: 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. doi: 10.5664/jcsm.1654.
citation: Schmid AA, Yaggi HK, Burrus N, McClain V, Austin C, Ferguson J, Fragoso C, Sico JJ, Miech EJ, Matthias MS, Williams LS, Bravata DM. Circumstances and consequences of falls among people with chronic stroke. J Rehabil Res Dev. 2013;50(9):1277-86. doi: 10.1682/JRRD.2012.11.0215.
citation: Zis P, Spengos K, Manios E, Vemmos K, Zis V, Dimopoulos MA, Zakopoulos N. Ambulatory blood pressure monitoring in acute stroke: the importance of time rate of blood pressure variation. Blood Press Monit. 2012 Oct;17(5):220-1; author reply 221-2. doi: 10.1097/MBP.0b013e3283588e8a. No abstract available.