Upper Airway Stability During Wakefulness and Sleep

Sleep Apnea Syndromes Clinical Trial

Official title:

Upper Airway Stability During Wakefulness and Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893552
• Other study ID #: Study 2015/01OCT/521
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: March 2019
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

• Patients with COPD

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Snoring

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Flow limitation during NEP application	see above, using pneumotachograph	measurement done immediately after inclusion, one time