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Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01100554
First received: April 7, 2010
Last updated: April 11, 2010
Last verified: April 2010
History of Changes

April 7, 2010
April 11, 2010
October 2009
June 2010   (final data collection date for primary outcome measure)
Upper airway collapsibility [ Designated as safety issue: Yes ]
The severity of upper aiwray collapses in different sedative levels will be evaluated by the sleep endoscopy. The correlation between the disease severities and airway collapsibilities will be evaluated.
Same as current
Complete list of historical versions of study NCT01100554 on ClinicalTrials.gov Archive Site
Mandible advancement response and oral appliance response [ Time Frame: 6 month and 1 year after oral appliance ] [ Designated as safety issue: No ]
Patients with response to mandible advancement will be referred to oral appliance to treat OSA. The treatment outcome will be followed.
Same as current
Not Provided
Not Provided
 
Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy
Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Bronchoscopy
  • Obstructive Sleep Apnea
  • Conscious Sedation
Device: Sleep endoscopy
Conscious sedation will be done under intravenous propofol infusion. The sedative level would be monitored and adjusted accord to the Bispectral Index monitor. After the adequate sedative level is achieved, a bronchoscopy (Olympus, BF) was inserted from the right nostril. The velopharynx, oropharynx, larynx, and hypopharynx obstructions were evaluated.
Other Names:
  • Bispectral Index
  • electroencephalograms(EEG)
  • electromyograms(EMG)
Experimental: all patients
Intervention: Device: Sleep endoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Yung-Lun Ni, MD 886-3-3281200 ext 5108 niyunglun@yahoo.com.tw
Taiwan
 
NCT01100554
980717A3
Yes
Yung-Lun Ni, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Study Director: Yu-Lun Lo, MD Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP