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

Primary Purpose

Sleep Apnea

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
3D endoscopic Fourier Domain OCT
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea focused on measuring APNEA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    3D endoscopic Fourier Domain OCT

    Arm Description

    3D endoscopic Fourier Domain OCT

    Outcomes

    Primary Outcome Measures

    obstructive upper airways in sleep disordered
    The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2011
    Last Updated
    October 28, 2022
    Sponsor
    University of California, Irvine
    Collaborators
    VA Long Beach Healthcare System, Beckman Laser Institute University of California Irvine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01485497
    Brief Title
    Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
    Official Title
    Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no participants enrolled
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Irvine
    Collaborators
    VA Long Beach Healthcare System, Beckman Laser Institute University of California Irvine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea
    Keywords
    APNEA

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3D endoscopic Fourier Domain OCT
    Arm Type
    Other
    Arm Description
    3D endoscopic Fourier Domain OCT
    Intervention Type
    Device
    Intervention Name(s)
    3D endoscopic Fourier Domain OCT
    Intervention Description
    Evaluation of Obstructive Sleep Apnea
    Primary Outcome Measure Information:
    Title
    obstructive upper airways in sleep disordered
    Description
    The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.
    Time Frame
    8 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or Female age 18-65 years has no history of obstructive sleep apnea Male or Female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea Male or Female age 18-65 years has been diagnose severe obstructive sleep apnea Exclusion Criteria: Pregnant women. Breastfeeding women. Unable to understand or give consent to the study. Currently taking drugs that are sensitive to light. Currently taking routine anti-convulsion, sedative or antihistamine drugs. Currently taking immuno-suppressive drug therapy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Zhang, PhD
    Organizational Affiliation
    UCI Beckman Laser Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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