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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984308
First Posted: September 25, 2009
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: March 31, 2015  
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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
Control The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services

Participant Flow:   Overall Study
    Intervention   Control
STARTED   110   115 
COMPLETED   92   109 
NOT COMPLETED   18   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intervention No text entered.
Control No text entered.
Total Total of all reporting groups

Baseline Measures
   Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 110   115   225 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.7  (10.4)   70.2  (10.1)   70  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1   0.9%      5   4.3%      6   2.7% 
Male      109  99.1%      110  95.7%      219  97.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sleep Apnea Diagnosis Rate   [ Time Frame: The entire study period (baseline and up to one-year) ]

2.  Primary:   Hypertension Control   [ Time Frame: One year ]

3.  Secondary:   Sleep Apnea Treatment Rate   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: dawn.bravata2@va.gov


Publications of Results:
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