Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy

Not Applicable

Completed

• Conditions: Sleep Apnea Syndrome
• Interventions: Procedure: Drug induced sleep endoscopy

• Registration Number: NCT02588300
• Lead Sponsor: Technical University of Munich

Brief Summary

This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE). The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography.

This study correlates the sedation level measured by entropy during DISE using propofol via a TCI pump with the local obstruction patterns of the upper airway according to the VOTE classification.

As OSAHS is a widespread disease and the DISE procedure has become a common tool for diagnosis and evaluation of further treatment, a growing number of research articles deal with this topic. These articles are available through pubmed.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-10-25
• Study First Submitted QC: 2015-10-25
• Study First Posted: 2015-10-27
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• documented sleep apnea Syndrome with an AHI > 5 diagnosed by polysomnography

Exclusion Criteria

• active infection
• performed oral, head or neck surgery, pregnancy,
• ASA classification III or higher,
• chronic use of alcohol, sedatives or illicit drugs and chronic
• obstructive pulmonary disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug induced sleep endoscopy	Drug induced sleep endoscopy	Patients upper airway is assessed by drug induced sleep endoscopy

Primary Outcome Measures

Name	Time	Method
collapse of the upper airway according to the VOTE classification	30 minutes

Trial Locations

Locations (1)

Klinik für Anaesthesiologie; 🇩🇪 Munich, Bayern, Germany