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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01485497
• Other study ID #: 20118075
• Status: Withdrawn
• Phase: Phase 1
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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