Upper Airway Stability During Wakefulness and Sleep

• Sponsor: Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT03893552
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Actual Duration (Months): 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes; Snoring	Device: Negative expiratory pressure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Upper Airway Stability During Wakefulness and Sleep
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Dec 30, 2016
• Actual Study Completion Date: Dec 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Measure of Flow limitation during NEP application [measurement done immediately after inclusion, one time]

   see above, using pneumotachograph

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Exclusion Criteria:

• Patients with COPD

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ALBDEWI Mohamad Ammar, Phd studant, Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT03893552
• Other Study ID Numbers: Study 2015/01OCT/521
• First Posted: Mar 28, 2019
• Last Update Posted: Mar 28, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ALBDEWI Mohamad Ammar, Phd studant, Université Catholique de Louvain: Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Snoring

Study Results

No Results Posted as of Mar 28, 2019