NCT01100554

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

April 13, 2010

Status Verified

April 1, 2010

Enrollment Period

8 months

First QC Date

April 7, 2010

Last Update Submit

April 11, 2010

Conditions

BronchoscopyObstructive Sleep ApneaConscious Sedation

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Mandible advancement response and oral appliance response

    6 month and 1 year after oral appliance

Study Arms (1)

all patients

EXPERIMENTAL
Device: Sleep endoscopy

Interventions

Sleep endoscopyDEVICE

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.

Also known as: Bispectral Index, electroencephalograms(EEG), electromyograms(EMG)
all patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department or Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 17579877BACKGROUND

  • 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.

    PMID: 18327599BACKGROUND

  • 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.

    PMID: 25979098DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Consciousness MonitorsElectroencephalographyElectromyography

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and SuppliesDiagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMyography

Study Officials

  • Yu-Lun Lo, MD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Yung-Lun Ni, MD

CONTACT

886-3-3281200niyunglun@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 9, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Last Updated

April 13, 2010

Record last verified: 2010-04

Locations

TW(1)