NCT01629862|CompletedPhase 2ResultsDMC
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Sponsor study identifier
interventional
53
1 country
2
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 8, 2012
Actual (reported)June 28, 2012
Actual (reported)February 2017
Actual (reported)February 2017
Actual (reported)February 19, 2018
Actual (reported)Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).
Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline.
3 months (compared to baseline)
Therapeutic continuous positive airway pressure (CPAP).
Sham (non-therapeutic) continuous positive airway pressure.
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Bakker JP, Baltzis D, Tecilazich F, Chan RH, Manning WJ, Neilan TG, Wallace ML, Hudson M, Malhotra A, Patel SR, Veves A. The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Apr;17(4):474-483. doi: 10.1513/AnnalsATS.201905-378OC.
Aristidis Veves, MD
Beth Israel Deaconess Medical Center
Sanjay R Patel, MD
University of Pittsburgh
53 participants (actual enrollment reported by the registry).
First Submitted
May 8, 2012
First Posted
June 28, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
May 28, 2019
Results First Posted
February 19, 2018
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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