Natural Sleep and Drug-induced Sleep Endoscopy
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

Intervention name(s): Sleep endoscopy during propofol induced sleep
Intervention type(s): Other
Intervention description(s): It will be performed a sleep endoscopy during drug induced sleep endoscopy
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: sleep endoscopy; sedation