Sleep Apnea Syndromes Clinical Trial
Official title:
Upper Airway Stability During Wakefulness and Sleep
Verified date | March 2019 |
Source | Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
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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