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Completed

NCT Number: NCT03004014

Natural Sleep and Drug-induced Sleep Endoscopy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep endoscopy during propofol induced sleep

Other

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

Primary outcomes

  1. The VOTE Endoscopic Classification

    Time frame: Immediately, during the procedure

    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 outcomes

  1. Peak inspiratory flow

    Time frame: Immediately, during the procedure

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

Sponsors and collaborators

Lead sponsor

Pedro Rodrigues Genta

Other

Registry information

Official study title

Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy Among Obstructive Sleep Apnea Subjects Referred for Surgical Treatment

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 28, 2016
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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