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

Primary Purpose

Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Drug induced sleep endoscopy
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Klinik für Anaesthesiologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug induced sleep endoscopy

Arm Description

Patients upper airway is assessed by drug induced sleep endoscopy

Outcomes

Primary Outcome Measures

collapse of the upper airway according to the VOTE classification

Secondary Outcome Measures

Full Information

First Posted
October 25, 2015
Last Updated
April 21, 2016
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02588300
Brief Title
Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug induced sleep endoscopy
Arm Type
Experimental
Arm Description
Patients upper airway is assessed by drug induced sleep endoscopy
Intervention Type
Procedure
Intervention Name(s)
Drug induced sleep endoscopy
Intervention Description
Titration of propofol using a target controlled Infusion pump and description of the upper airway according to the VOTE classification
Primary Outcome Measure Information:
Title
collapse of the upper airway according to the VOTE classification
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guenther Edenharter, MD
Organizational Affiliation
Klinikum rechts der Isar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Anaesthesiologie
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28364198
Citation
Heiser C, Fthenakis P, Hapfelmeier A, Berger S, Hofauer B, Hohenhorst W, Kochs EF, Wagner KJ, Edenharter GM. Drug-induced sleep endoscopy with target-controlled infusion using propofol and monitored depth of sedation to determine treatment strategies in obstructive sleep apnea. Sleep Breath. 2017 Sep;21(3):737-744. doi: 10.1007/s11325-017-1491-8. Epub 2017 Mar 31.
Results Reference
derived

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

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