Upper Airway Stability During Wakefulness and Sleep

NCT03893552 | Completed DMC

• 1 other identifier: Study 2015/01OCT/521
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Apnea Syndromes; Snoring

Keywords

Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing

Outcome Measures

Primary Outcomes (1)

• Measure of Flow limitation during NEP application

  see above, using pneumotachograph

  measurement done immediately after inclusion, one time

Study Arms (1)

Patient with sleep disordered breathing symptoms

EXPERIMENTAL

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.

Device: Negative expiratory pressure

Interventions

Negative expiratory pressure 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.

Patient with sleep disordered breathing symptoms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with COPD

Sponsors & Collaborators

• Université Catholique de Louvain: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes; Snoring

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd studant

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: March 1, 2016
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: March 28, 2019

Record last verified: 2019-03