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

Technical University of Munich

Status: Completed

Conditions: Sleep Apnea Syndrome

Treatments: Procedure: Drug induced sleep endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02588300

5782/13

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

Drug induced sleep endoscopy

Experimental group

Description:

Patients upper airway is assessed by drug induced sleep endoscopy

Treatment:

Procedure: Drug induced sleep endoscopy