- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02588300
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
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bayern
-
Munich, Bayern, Germany, 81675
- Klinik für Anaesthesiologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Investigators
- Principal Investigator: Guenther Edenharter, MD, Klinikum rechts der Isar
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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