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Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01100554
Collaborator
(none)
120
Enrollment
1
Location
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sleep endoscopy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy
Study Start Date :
Oct 1, 2009
Anticipated Primary Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: all patients

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Upper airway collapsibility []

      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.

    Secondary Outcome Measures

    1. Mandible advancement response and oral appliance response [6 month and 1 year after oral appliance]

      Patients with response to mandible advancement will be referred to oral appliance to treat OSA. The treatment outcome will be followed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department or Thoracic Medicine, Chang Gung Memorial Hospital Taipei Taiwan

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    • Study Director: Yu-Lun Lo, MD, Chang Gung Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01100554
    Other Study ID Numbers:
    • 980717A3
    First Posted:
    Apr 9, 2010
    Last Update Posted:
    Apr 13, 2010
    Last Verified:
    Apr 1, 2010
    Additional relevant MeSH terms:
    Sleep Apnea, Obstructive

    Study Results

    No Results Posted as of Apr 13, 2010