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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01485497

Enrollment

Registered

2011-12-05

Start date

2011-05-31

Completion date

2014-03-31

Last updated

2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

APNEA

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.

Interventions

DEVICE3D endoscopic Fourier Domain OCT

Evaluation of Obstructive Sleep Apnea

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026