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Natural Sleep and Drug-induced Sleep Endoscopy

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sleep endoscopy during propofol induced sleep
Sponsored by
Pedro Rodrigues Genta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring sleep endoscopy, sedation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Natural Sleep

Propofol Induced Sleep

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Peak inspiratory flow
Peak inspiratory flow measured during both natural and drug-induced sleep endoscopy

Full Information

First Posted
August 4, 2016
Last Updated
July 29, 2018
Sponsor
Pedro Rodrigues Genta
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1. Study Identification

Unique Protocol Identification Number
NCT03004014
Brief Title
Natural Sleep and Drug-induced Sleep Endoscopy
Official Title
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy Among Obstructive Sleep Apnea Subjects Referred for Surgical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pedro Rodrigues Genta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objective: to compare natural sleep endoscopy to drug induced sleep with propofol. The study population will include 28 patients who are candidates to surgical treatment. Methods Detailed clinical history and physical examination will be performed before natural sleep endoscopy. A 2-hour fast will be required. During both natural sleep and propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter (model TC-500XG; Millar).The nasopharynx will be numbed with xylocaine (10%) and oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and placed at the tongue base as confirmed by visual inspection of the oropharynx.A 2.8mm pediatric bronchoscope (Olympus) will be passed through the mask and into the other nostril. A nasal mask will be fitted and a heated pneumotachograph with differential pressure transducer connected to the mask will quantify airflow. The endoscope will be located at velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.The VOTE Endoscopic Classification will be used to describe site and configuration of pharyngeal collapse in each study. The study will be scored by two experienced investigators, blind to the patient identification and type of study (natural sleep or drug-induced). Propofol-induced sleep will be performed at the operating room before surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep endoscopy, sedation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natural Sleep
Arm Type
No Intervention
Arm Description
OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep
Arm Title
Propofol Induced Sleep
Arm Type
Other
Arm Description
Sleep endoscopy during propofol induced sleep OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep
Intervention Type
Other
Intervention Name(s)
Sleep endoscopy during propofol induced sleep
Intervention Description
It will be performed a sleep endoscopy during drug induced sleep endoscopy
Primary Outcome Measure Information:
Title
The VOTE Endoscopic Classification
Description
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.
Time Frame
Immediately, during the procedure
Secondary Outcome Measure Information:
Title
Peak inspiratory flow
Description
Peak inspiratory flow measured during both natural and drug-induced sleep endoscopy
Time Frame
Immediately, during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI less than 35kg/m2 Apnea-hypopnea index > 5 events/hour of sleep Clinical indication of surgical treatment for sleep apnea Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro R Genta, Post Doc
Organizational Affiliation
Sleep Laboratoy, Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
32029070
Citation
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.
Results Reference
derived

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Natural Sleep and Drug-induced Sleep Endoscopy

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