NCT03893552|CompletedDMC
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Sponsor study identifier
interventional
100
0 countries
N/A
Study Start
March 1, 2016
Actual (reported)Primary Completion
December 30, 2016
Actual (reported)Study Completion
December 30, 2016
Actual (reported)Negative expiratory pressure is a technique that has been the focus of many studies in the last few years. Airway response to the application of a negative expiratory pressure (NEP) can be used to detect the presence of upper airway collapsibility. In normal subjects, an increase in expiratory flow is observed while in patients with collapsible upper airway, the flow will show a transient decrease due to airway collapse. The objectives of this study will be initially to investigate the diagnostic utility of this technique as a noninvasive measurement of the stability of the upper airway in sleep-related breathing disorders. Secondly, we aim to see the sites of airway obstructions, discovered by NEP, through nasal endoscopy. Finally, we aim at testing the utility of NEP technique in the evaluation of therapeutic response. For this purpose, we will apply it in patients before and after airway stabilization interventions like ENT surgery, oropharyngeal exercises, orthodontic mandibular advancement electrical stimulation of the hypoglossal nerve.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2016
Actual (reported)December 30, 2016
Actual (reported)December 30, 2016
Actual (reported)March 26, 2019
Actual (reported)March 28, 2019
Actual (reported)Measure of Flow limitation during NEP application
see above, using pneumotachograph
measurement done immediately after inclusion, one time
Patients referring to the clinic of sleep disorders will be asked to participate in this study. A negative expiratory pressure will be applied via a cough-assist attached to a facial mask.
Using a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring.
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100 participants (actual enrollment reported by the registry).
First Submitted
March 26, 2019
First Posted
March 28, 2019
Study Start
March 1, 2016
Actual (reported)Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study
Primary Completion
December 30, 2016
Actual (reported)Study Completion
December 30, 2016
Actual (reported)Last Updated
March 28, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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