Upper Airway Stability During Wakefulness and Sleep
Primary Purpose
Sleep Apnea Syndromes, Snoring
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Negative expiratory pressure
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea Syndromes focused on measuring Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
- Patients with COPD
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with sleep disordered breathing symptoms
Arm Description
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.
Outcomes
Primary Outcome Measures
Measure of Flow limitation during NEP application
see above, using pneumotachograph
Secondary Outcome Measures
Full Information
NCT ID
NCT03893552
First Posted
March 26, 2019
Last Updated
March 27, 2019
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03893552
Brief Title
Upper Airway Stability During Wakefulness and Sleep
Official Title
Upper Airway Stability During Wakefulness and Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 30, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Snoring
Keywords
Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with sleep disordered breathing symptoms
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Negative expiratory pressure
Intervention Description
Using a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring.
Primary Outcome Measure Information:
Title
Measure of Flow limitation during NEP application
Description
see above, using pneumotachograph
Time Frame
measurement done immediately after inclusion, one time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
Patients with COPD
12. IPD Sharing Statement
Learn more about this trial
Upper Airway Stability During Wakefulness and Sleep
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