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Natural Sleep and Drug-induced Sleep Endoscopy

NCT03004014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-07-31

No results posted yet for this study

Summary

Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical treatment.

Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the night. Propofol induced sleep will be performed at the operating room before surgery. The VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be used to compare site and configuration of collapse between studies. Peak inspiratory flow will also be compared between studies.

Conditions

Interventions

OTHER

Sleep endoscopy during propofol induced sleep

It will be performed a sleep endoscopy during drug induced sleep endoscopy

Sponsors & Collaborators

  • Pedro Rodrigues Genta

    lead OTHER

Principal Investigators

  • Pedro R Genta, Post Doc · Sleep Laboratoy, Heart Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004014 on ClinicalTrials.gov