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

April 21, 2016 updated by: Technical University of Munich

Evaluation of the Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy According to the Munich Sleep Video Protocol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Munich, Bayern, Germany, 81675
        • Klinik für Anaesthesiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug induced sleep endoscopy
Patients upper airway is assessed by drug induced sleep endoscopy
Procedure: Drug induced sleep endoscopy
Titration of propofol using a target controlled Infusion pump and description of the upper airway according to the VOTE classification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
collapse of the upper airway according to the VOTE classification
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Guenther Edenharter, MD, Klinikum Rechts der Isar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 25, 2015

First Submitted That Met QC Criteria

October 25, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5782/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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