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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3D endoscopic Fourier Domain OCT

Group Type OTHER

3D endoscopic Fourier Domain OCT

Intervention Type DEVICE

Evaluation of Obstructive Sleep Apnea

Interventions

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3D endoscopic Fourier Domain OCT

Evaluation of Obstructive Sleep Apnea

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes