Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy
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
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 25, 2015
CompletedFirst Posted
Study publicly available on registry
October 27, 2015
CompletedApril 22, 2016
April 1, 2016
2.3 years
October 25, 2015
April 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
collapse of the upper airway according to the VOTE classification
30 minutes
Study Arms (1)
Drug induced sleep endoscopy
EXPERIMENTALPatients upper airway is assessed by drug induced sleep endoscopy
Interventions
Titration of propofol using a target controlled Infusion pump and description of the upper airway according to the VOTE classification
Eligibility Criteria
You may qualify if:
- documented sleep apnea Syndrome with an AHI \> 5 diagnosed by polysomnography
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Anaesthesiologie
Munich, Bavaria, 81675, Germany
Related Publications (1)
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.
PMID: 28364198DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guenther Edenharter, MD
Klinikum rechts der Isar
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2015
First Posted
October 27, 2015
Study Start
July 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
April 22, 2016
Record last verified: 2016-04