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Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy

Primary Purpose

Bronchoscopy, Obstructive Sleep Apnea, Conscious Sedation

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sleep endoscopy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department or Thoracic Medicine, Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all patients

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
April 7, 2010
Last Updated
April 11, 2010
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01100554
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchoscopy, Obstructive Sleep Apnea, Conscious Sedation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
all patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sleep endoscopy
Other Intervention Name(s)
Bispectral Index, electroencephalograms(EEG), electromyograms(EMG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper airway collapsibility
Description
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 Measure Information:
Title
Mandible advancement response and oral appliance response
Description
Patients with response to mandible advancement will be referred to oral appliance to treat OSA. The treatment outcome will be followed.
Time Frame
6 month and 1 year after oral appliance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Lun Ni, MD
Phone
886-3-3281200
Ext
5108
Email
niyunglun@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Lun Lo, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department or Thoracic Medicine, Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Lun Ni, MD
Email
niyunglun@yahoo.com.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
17579877
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.
Results Reference
background
PubMed Identifier
18327599
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.
Results Reference
background
PubMed Identifier
25979098
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.
Results Reference
derived

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Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy

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