Upper Airway Stability During Wakefulness and Sleep

Not Applicable

Completed

• Conditions: Snoring; Sleep Apnea Syndromes
• Interventions: Device: Negative expiratory pressure

• Registration Number: NCT03893552
• Lead Sponsor: Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2016-12-30
• Study Completion: 2016-12-30
• Status Verified: 2019-03
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Study First Posted: 2019-03-28
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Exclusion Criteria

• Patients with COPD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with sleep disordered breathing symptoms	Negative expiratory pressure	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.

Primary Outcome Measures

Name	Time	Method
Measure of Flow limitation during NEP application	measurement done immediately after inclusion, one time	see above, using pneumotachograph