Clinical trial NCT01100554: Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy
Official title: Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchoscopy
Obstructive Sleep Apnea
Conscious Sedation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the upper airway collapsibility by sleep endoscopy in different sedative levels. Propofol pump infusion will be used to achieve conscious sedation. Bispectral Index monitor will be applied to the monitor the conscious level. Two different sedative levels (BIS 65-75, 50-60) will be achieved for upper airway evaluation. The severities of upper airway obstruction will be evaluated the correlation to the disease severities. Mandible advancement will be done to evaluate the response for oral appliance.

Detailed description: Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a disorder characterized by recurrent upper airway collapse during sleep. Clinical consequences as increased cardiovascular events and automobile accidents were noted. Polysomnography is diagnostic while continuous positive airway pressure (CPAP) is the standard treatment. The adherence of CPAP treatment remained suboptimal, between 29 to 83%. In selected cases, alternative treatments were considered useful. However, how to choose candidates is still an issue.

Sleep endoscopy has been introduced since 1991 to allow direct visualization of the upper airway under sleep simulation. It predicts better outcome in non-adherent OSAHS patients who received alternative treatment. However, the ideal dose, drug, and sedative depth were not known.

Bispectral Index (BIS) monitor is a noninvasive neurophysiological monitoring device that been introduced since late 1990's. By applying a sensor to the forehead, the BIS obtained electroencephalograms(EEG) and electromyograms(EMG) which were transformed into simplified scaled numbers through 0-100. It has been applied in the real time monitor of anesthesia depth during operation or recovery, monitor of sleep in critical illness patients and gastrointestinal endoscopy sedation.

This study focuses on CPAP non-adherent patients. It evaluates the upper airway collapsibility in awake and two different sedative levels, BIS 65-75 (light sedation) and BIS 50-60(deep sedation). Conscious sedation will be achieved by propofol pump infusion. No benzodiazepam or opioid are used to avoid the effect of upper airway muscle tone and respiratory drive. The patency over the velopharynx, oropharynx, larynx, and hypopharynx will be recorded. Specific obstruction patterns such as tongue base retraction, epiglottis anterior-posterior decent, omega-shaped epiglottis,and bilateral arytenoids anterior drawing will also be recorded. The correlation of the upper airway collapsibility between sedative depth and sleep stages (ex. NREM vs. REM) will be evaluated. Besides, mandible advancement will be done under deep sedation. The response will guide further treatment choice for those CPAP non-adherent patient.

Eligibility criteria: Inclusion Criteria:

* Normal volunteer: cases with no sleep apnea symptoms and AHI\<5
* Study cases: CPAP non-adherent sleep apnea patient

Exclusion Criteria:

* ASA \> 3
* allergy to propofol, xylocaine, or food (egg, bean, milk)
* congestive heart failure
* severe obstructive airway disease
* head injury, seizure, cerebrovascular accident history
* age \< 18 year-old

Primary outcomes:
measure: Upper airway collapsibility
Secondary outcomes:
measure: Mandible advancement response and oral appliance response
timeFrame: 6 month and 1 year after oral appliance
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department or Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Lun Lo, MD
role: STUDY_DIRECTOR
References:
citation: Kotecha BT, Hannan SA, Khalil HM, Georgalas C, Bailey P. Sleep nasendoscopy: a 10-year retrospective audit study. Eur Arch Otorhinolaryngol. 2007 Nov;264(11):1361-7. doi: 10.1007/s00405-007-0366-1. Epub 2007 Jun 20.
citation: Bachar G, Feinmesser R, Shpitzer T, Yaniv E, Nageris B, Eidelman L. Laryngeal and hypopharyngeal obstruction in sleep disordered breathing patients, evaluated by sleep endoscopy. Eur Arch Otorhinolaryngol. 2008 Nov;265(11):1397-402. doi: 10.1007/s00405-008-0637-5. Epub 2008 Mar 8.
citation: Lo YL, Ni YL, Wang TY, Lin TY, Li HY, White DP, Lin JR, Kuo HP. Bispectral Index in Evaluating Effects of Sedation Depth on Drug-Induced Sleep Endoscopy. J Clin Sleep Med. 2015 Sep 15;11(9):1011-20. doi: 10.5664/jcsm.5016.