Skip to main content
OpenTrials
Completed

NCT Number: NCT02588300

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Anaesthesiologie

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug induced sleep endoscopy

Procedure

Titration of propofol using a target controlled Infusion pump and description of the upper airway according to the VOTE classification

Primary outcomes

  1. collapse of the upper airway according to the VOTE classification

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2015
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.