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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01485497
Other study ID # 20118075
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date May 2011
Est. completion date March 2014

Study information

Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

Device:
3D endoscopic Fourier Domain OCT
Evaluation of Obstructive Sleep Apnea

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine, VA Long Beach Healthcare System

Outcome

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