NCT03004014

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

August 4, 2016

Last Update Submit

July 29, 2018

Conditions

Obstructive Sleep Apnea

Keywords

sleep endoscopysedation

Outcome Measures

Primary Outcomes (1)

  • The VOTE Endoscopic Classification

    Comparison of site and configuration of endoscopy findings between the natural and drug-induced sleep endoscopy. The VOTE Endoscopic Classification describes the patterns and the degree of obstruction during sleep endoscopy.

    Immediately, during the procedure

Secondary Outcomes (1)

  • Peak inspiratory flow

    Immediately, during the procedure

Study Arms (2)

Natural Sleep

NO INTERVENTION

OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep

Propofol Induced Sleep

OTHER

Sleep endoscopy during propofol induced sleep OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep

Other: Sleep endoscopy during propofol induced sleep

Interventions

Sleep endoscopy during propofol induced sleepOTHER

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

Propofol Induced Sleep

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI less than 35kg/m2
  • Apnea-hypopnea index \> 5 events/hour of sleep
  • Clinical indication of surgical treatment for sleep apnea

You may not qualify if:

  • Severe or decompensated cardiac or respiratory diseases
  • Previous pharyngeal surgery
  • Tonsils grade III or IV
  • Other sleep disturbance (parasomnias, primary insomnia, narcolepsy)
  • Sedative medication use (opioids, benzodiazepines and muscle relaxants)
  • Uncontrolled diabetes or hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (1)

  • Ordones AB, Grad GF, Cahali MB, Lorenzi-Filho G, Sennes LU, Genta PR. Comparison of upper airway obstruction during zolpidem-induced sleep and propofol-induced sleep in patients with obstructive sleep apnea: a pilot study. J Clin Sleep Med. 2020 May 15;16(5):725-732. doi: 10.5664/jcsm.8334. Epub 2020 Feb 7.

    PMID: 32029070DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Pedro R Genta, Post Doc

    Sleep Laboratoy, Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2016

First Posted

December 28, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Locations

BR(1)