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

Sleep Apnea Syndrome Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02588300
• Other study ID #: 5782/13
• Status: Active, not recruiting
• Phase: N/A
• First received: October 25, 2015
• Last updated: October 25, 2015
• Start date: July 2013
• Est. completion date: November 2015

Study information

• Verified date: October 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie	Munich	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	collapse of the upper airway according to the VOTE classification		30 minutes	No