Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)

This study has been withdrawn prior to enrollment.
(no participants enrolled)
Sponsor:
Collaborators:
VA Long Beach Healthcare System
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01485497
First received: August 2, 2011
Last updated: August 5, 2015
Last verified: August 2015
  Purpose
The purpose of this study is to determine whether the Optical coherence tomography (OCT) can image the structure and geometry of hollow organs of the upper airway in sleep disorder. The research can identify the obstruction sites that help the select the appropriate treatment for potential surgical candidates.

Condition Intervention Phase
Sleep Apnea
Device: 3D endoscopic Fourier Domain OCT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • obstructive upper airways in sleep disordered [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.


Enrollment: 0
Study Start Date: May 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
3D endoscopic Fourier Domain OCT
3D endoscopic Fourier Domain OCT
Device: 3D endoscopic Fourier Domain OCT
Evaluation of Obstructive Sleep Apnea

Detailed Description:

The National Commission on Sleep Disorders Research estimated that 18 million Americans suffer from obstructive sleep apnea (OSA) The majority of them are undiagnosed and untreated at this time.

The current diagnostic gold standard for OSA is in-laboratory, a full night polysomnography (PSG). However, PSG is unable to provide information on upper airway structure and anatomy, and cannot identify the obstruction sites. OSA can lead to severe health complications including hypertension, heart failure, memory impairment, motor vehicle and work accidents, decreased work productivity, and increased risk of death.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female age 18-65 years has no history of obstructive sleep apnea
  2. Male or Female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea
  3. Male or Female age 18-65 years has been diagnose severe obstructive sleep apnea

Exclusion Criteria:

  1. Pregnant women.
  2. Breastfeeding women.
  3. Unable to understand or give consent to the study.
  4. Currently taking drugs that are sensitive to light.
  5. Currently taking routine anti-convulsion, sedative or antihistamine drugs.
  6. Currently taking immuno-suppressive drug therapy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01485497

Sponsors and Collaborators
University of California, Irvine
VA Long Beach Healthcare System
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Jun Zhang, PhD UCI Beckman Laser Institute
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Jun Zhang, PhD, Assistant Project Scientist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01485497     History of Changes
Other Study ID Numbers: NIH/LAMMP-2011-8075 
Study First Received: August 2, 2011
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
APNEA

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 21, 2016