Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
VA Long Beach Healthcare System
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01485497
First received: August 2, 2011
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea)
 Device: Evaluation of Obstructive Sleep Apnea
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • obstructive upper airways in sleep disordered [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: sleep apnea
Evaluation of Obstructive Sleep Apnea
 Device: Evaluation of Obstructive Sleep Apnea
Evaluation of Obstructive Sleep Apnea

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485497

Locations
United States, California
UCI Beckman Laser Institute
Irvine, California, United States, 92612
VA Hopital Long Beach
Long Beach, California, United States, 90822
Sponsors and Collaborators
Montana Compton
VA Long Beach Healthcare System
Investigators
Principal Investigator: Jun Zhang, PhD UCI Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01485497     History of Changes
Other Study ID Numbers: NIH1K25HL102055 - 01A1
Study First Received: August 2, 2011
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
APNEA

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013