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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Drug induced sleep endoscopy

Patients upper airway is assessed by drug induced sleep endoscopy

Group Type EXPERIMENTAL

Drug induced sleep endoscopy

Intervention Type PROCEDURE

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

Interventions

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Drug induced sleep endoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No