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

Phase 1

Withdrawn

• Conditions: Sleep Apnea
• Interventions: Device: 3D endoscopic Fourier Domain OCT

• Registration Number: NCT01485497
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D endoscopic Fourier Domain OCT	3D endoscopic Fourier Domain OCT	3D endoscopic Fourier Domain OCT

Primary Outcome Measures

Name	Time	Method
obstructive upper airways in sleep disordered	8 hours	The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.