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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
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 26, 2019
    Last Updated
    March 27, 2019
    Sponsor
    Université Catholique de Louvain
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    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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