NCT01130090|CompletedDMC
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Sponsor study identifier
interventional
10
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome, this study aims to determine if it is better, in terms of efficacy and patient-ventilator synchronisation to use
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
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.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 3, 2010
Actual (reported)May 25, 2010
Actual (reported)November 2010
Actual (reported)November 2010
Actual (reported)Sleep structure
Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)
Night 1
Sleep structure
Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)
Night 2
Sleep structure
Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)
Night 3
Transcutaneous capnography (PtcCO2)
Night 1
Transcutaneous capnography (PtcCO2)
Night 2
Transcutaneous capnography (PtcCO2)
Night 3
Correlation between microarousal index and autonomic arousal index
Night 1
Correlation between microarousal index and autonomic arousal index
Night 2
3 consecutive nights in randomized order, in either "S" (Spontaneous) mode, "ST" (Spontaneous/Timed) mode with a back-up rate under spontaneous respiratory rate of the patient, or in "ST" (Spontaneous/Timed) mode with a back-up rate at least 2 cycles/minute above spontaneous nocturnal respiratory rate. Each assessment will include complete polysomnographic recording (sleep study) as well as SpO2, PtcCO2, pneumotachograph (flow), mask pressure, quantitative assessment of patient-ventilator synchronisation, central or obstructive apnea and hypopnea, data of built-in software, and rating of patient comfort
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Geneva University hospital - Sleep laboratory
Geneva, 1211, Switzerland
Georges M, Adler D, Contal O, Espa F, Perrig S, Pepin JL, Janssens JP. Reliability of Apnea-Hypopnea Index Measured by a Home Bi-Level Pressure Support Ventilator Versus a Polysomnographic Assessment. Respir Care. 2015 Jul;60(7):1051-6. doi: 10.4187/respcare.03633. Epub 2015 Mar 3.
Contal O, Adler D, Borel JC, Espa F, Perrig S, Rodenstein D, Pepin JL, Janssens JP. Impact of different backup respiratory rates on the efficacy of noninvasive positive pressure ventilation in obesity hypoventilation syndrome: a randomized trial. Chest. 2013 Jan;143(1):37-46. doi: 10.1378/chest.11-2848.
Jean-Paul Janssens, MD
University Hospital, Geneva
First Submitted
May 3, 2010
First Posted
May 25, 2010
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Comparison of MAG and Fish Oil Efficacy
Study Completion
November 2010
Actual (reported)Last Updated
February 24, 2011
Record last verified: 2011-02
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Source: ClinicalTrials.gov.
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