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Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease (Go To Sleep)

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ClinicalTrials.gov Identifier: NCT00984308
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : September 1, 2015
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obstructive Sleep Apnea
Stroke
Transient Ischemic Attack
Hypertension
Intervention Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Enrollment 225
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group 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
Period Title: Overall Study
Started 110 115
Completed 92 109
Not Completed 18 6
Arm/Group Title Intervention Control Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 110 115 225
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 115 participants 225 participants
69.7  (10.4) 70.2  (10.1) 70  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 115 participants 225 participants
Female
1
   0.9%
5
   4.3%
6
   2.7%
Male
109
  99.1%
110
  95.7%
219
  97.3%
1.Primary Outcome
Title Sleep Apnea Diagnosis Rate
Hide Description The number of patients with a diagnosis of sleep apnea
Time Frame The entire study period (baseline and up to one-year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intervention patients had polysomnography at baseline (n=102) whereas control patients either had polysomnography as part of usual care (n=7) or at the end of the study as part of the study protocol (n=85). The n=7 patients who had polysomnography as part of usual care were included in the analysis for this outcome.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 102 7
Measure Type: Number
Unit of Measure: participants
58 5
2.Primary Outcome
Title Hypertension Control
Hide Description Medication-Adjusted Systolic Blood Pressure
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Intervention Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 110 115
Mean (Standard Deviation)
Unit of Measure: mm Hg
157.4  (25) 161.6  (24.3)
3.Secondary Outcome
Title Sleep Apnea Treatment Rate
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Among the 58 intervention patients with a diagnosis of sleep apnea, CPAP data were available for 57. Among the 7 control patients who received polysomnography as part of usual care, 5 had sleep apnea: CPAP data were available for 4 patients (2 did not receive any CPAP and 2 had CPAP therapy), the data card was unavailable for 1 patient.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 57 2
Measure Type: Number
Unit of Measure: participants
22 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/110 (4.55%)      2/115 (1.74%)    
Cardiac disorders     
Congestive heart failure (CHF)  3/110 (2.73%)  3 0/115 (0.00%)  0
Acute myocardial infarction (AMI)  0/110 (0.00%)  0 0/115 (0.00%)  0
General disorders     
DEATH  1/110 (0.91%)  1 0/115 (0.00%)  0
Nervous system disorders     
stroke [1]  0/110 (0.00%)  0 1/115 (0.87%)  1
Transient ischemic attack (TIA)  1/110 (0.91%)  1 1/115 (0.87%)  1
[1]
new stroke event in patient with history of cerebrovascular disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/110 (20.00%)      30/115 (26.09%)    
General disorders     
Falls  22/110 (20.00%)  22 30/115 (26.09%)  30
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dawn M. Bravata, MD
Organization: Department of Veterans Affairs
Phone: 317-988-2676
Publications of Results:
Schmid AA, Yaggi HK, Burrus N, McClain V, Austin C, Ferguson J, Fragoso C, Sico J, Ofner S, Miech EJ, Matthias MS, Williams LS, Bravata DM. The Circumstances and Consequences of Post-Stroke Falls. [Abstract]. Stroke; A Journal of Cerebral Circulation. 2013 Feb 1; 44(2):TP318.
Bravata DM, Sico JJ, Phipps MS, Yaggi HK. Response to ambulatory blood pressure monitoring in acute stroke: the importance of the time rate of blood pressure variation. Blood pressure monitoring. 2012 Oct 1; 17(5):221-222.
Other Publications:
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. Circulation. 2013 Jun 11;127(23):e841.
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00984308     History of Changes
Obsolete Identifiers: NCT00807417
Other Study ID Numbers: IIR 06-233
First Submitted: September 24, 2009
First Posted: September 25, 2009
Results First Submitted: March 31, 2015
Results First Posted: September 1, 2015
Last Update Posted: June 14, 2017