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

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 3D endoscopic Fourier Domain OCT
Device: 3D endoscopic Fourier Domain OCT
Evaluation of Obstructive Sleep Apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
obstructive upper airways in sleep disordered
Time Frame: 8 hours
The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine
VA Long Beach Healthcare System

Investigators

  • Principal Investigator: Jun Zhang, PhD, UCI Beckman Laser Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20118075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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