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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03893552
Other study ID # Study 2015/01OCT/521
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2016
Est. completion date December 30, 2016

Study information

Verified date March 2019
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 30, 2016
Est. primary completion date December 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

Exclusion Criteria:

- Patients with COPD

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Negative expiratory pressure
Using a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université Catholique de Louvain

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of Flow limitation during NEP application see above, using pneumotachograph measurement done immediately after inclusion, one time
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