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
  Purpose

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 Intervention
Bronchoscopy
Obstructive Sleep Apnea
Conscious Sedation
Device: Sleep endoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100554

Contacts
Contact: Yung-Lun Ni, MD 886-3-3281200 ext 5108 niyunglun@yahoo.com.tw

Locations
Taiwan
Department or Thoracic Medicine, Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Yung-Lun Ni, MD       niyunglun@yahoo.com.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: Yu-Lun Lo, MD Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: Yung-Lun Ni, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01100554     History of Changes
Other Study ID Numbers: 980717A3
Study First Received: April 7, 2010
Last Updated: April 11, 2010
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014