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Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea

NCT04729478 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-26

No results posted yet for this study

Summary

Drug-induced sleep endoscopy (DISE) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (OSA). This is due to the fact that it allows many patients to be examined in a daytime setting. This procedure uses sedative drugs to mimic natural sleep. However, associations with the site of upper airway (UA) collapse during natural sleep remain unclear.

The aim of this explorative study is to identify UA collapse in patients with OSA using endoscopic techniques as well as flow shape characteristics and sound analyses during natural and drug-induced sleep. Furthermore, we want to optimize the measurement set-up of natural sleep endoscopy (NSE).

Conditions

  • Sleep Apnea, Obstructive
  • Sleep Apnea
  • Sleep Apnea Syndromes
  • Apnea
  • Respiration Disorder
  • Respiratory Tract Disease
  • Dyssomnia
  • Sleep Disorders, Intrinsic
  • Sleep Wake Disorders
  • Nervous System Diseases
  • Hypnotics and Sedatives
  • Central Nervous System Depressants
  • Propofol
  • Midazolam
  • Physiological Effects of Drugs
  • General Anesthetics

Interventions

DEVICE

Drug-induced sleep endoscopy

An intravenous bolus injection of midazolam 1.5 mg will be used to induce sleep. Maintenance of sedated sleep will be obtained by a target-controlled infusion of propofol (2.0-3.0 µg/mL).

DEVICE

Natural sleep endoscopy

Endoscopy during natural sleep.

Sponsors & Collaborators

Principal Investigators

  • Olivier Vanderveken, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2022-08-31
Completion
2022-12-31

Countries

  • Belgium

Study Locations

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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 NCT04729478 on ClinicalTrials.gov