Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease (Go To Sleep)
Primary Purpose
Obstructive Sleep Apnea, Stroke, Transient Ischemic Attack
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, hypertension, brain ischemia
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
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
Outcomes
Primary Outcome Measures
Sleep Apnea Diagnosis Rate
The number of patients with a diagnosis of sleep apnea
Hypertension Control
Medication-Adjusted Systolic Blood Pressure
Secondary Outcome Measures
Sleep Apnea Treatment Rate
Full Information
NCT ID
NCT00984308
First Posted
September 24, 2009
Last Updated
May 15, 2017
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00984308
Brief Title
Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Acronym
Go To Sleep
Official Title
Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 23, 2008 (Actual)
Primary Completion Date
September 30, 2011 (Actual)
Study Completion Date
September 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Stroke, Transient Ischemic Attack, Hypertension
Keywords
sleep apnea, hypertension, brain ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
Arm Title
Control
Arm Type
Other
Arm Description
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
Intervention Type
Procedure
Intervention Name(s)
CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Intervention Description
Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.
Primary Outcome Measure Information:
Title
Sleep Apnea Diagnosis Rate
Description
The number of patients with a diagnosis of sleep apnea
Time Frame
The entire study period (baseline and up to one-year)
Title
Hypertension Control
Description
Medication-Adjusted Systolic Blood Pressure
Time Frame
One year
Secondary Outcome Measure Information:
Title
Sleep Apnea Treatment Rate
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M. Bravata, MD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22179539
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. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.
Results Reference
background
PubMed Identifier
23283859
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.
Results Reference
background
PubMed Identifier
23239837
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. Erratum In: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.
Results Reference
background
PubMed Identifier
21885958
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.
Results Reference
result
PubMed Identifier
22334806
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.
Results Reference
result
PubMed Identifier
24458967
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.
Results Reference
result
PubMed Identifier
22968110
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.
Results Reference
result
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Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
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