Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2015-01-31
2018-01-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Natural Sleep
OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep
No interventions assigned to this group
Propofol Induced Sleep
Sleep endoscopy during propofol induced sleep
OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep
Sleep endoscopy during propofol induced sleep
It will be performed a sleep endoscopy during drug induced sleep endoscopy
Interventions
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Sleep endoscopy during propofol induced sleep
It will be performed a sleep endoscopy during drug induced sleep endoscopy
Eligibility Criteria
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Inclusion Criteria
* Apnea-hypopnea index \> 5 events/hour of sleep
* Clinical indication of surgical treatment for sleep apnea
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Pedro Rodrigues Genta
OTHER
Responsible Party
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Pedro Rodrigues Genta
Principal Investigator
Principal Investigators
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Pedro R Genta, Post Doc
Role: PRINCIPAL_INVESTIGATOR
Sleep Laboratoy, Heart Institute
Locations
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Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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13900
Identifier Type: -
Identifier Source: org_study_id
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