Upper Airway Stability During Wakefulness and Sleep

NCT ID: NCT03893552

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2016-12-30

Brief Summary

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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

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Conditions

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Sleep Apnea Syndromes Snoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient with sleep disordered breathing symptoms

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.

Group Type EXPERIMENTAL

Negative expiratory pressure

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Patients with COPD
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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ALBDEWI Mohamad Ammar

Phd studant

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Study 2015/01OCT/521

Identifier Type: -

Identifier Source: org_study_id

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