- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01485497
Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or Female age 18-65 years has no history of obstructive sleep apnea
- Male or Female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea
- Male or Female age 18-65 years has been diagnose severe obstructive sleep apnea
Exclusion Criteria:
- Pregnant women.
- Breastfeeding women.
- Unable to understand or give consent to the study.
- Currently taking drugs that are sensitive to light.
- Currently taking routine anti-convulsion, sedative or antihistamine drugs.
- Currently taking immuno-suppressive drug therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 3D endoscopic Fourier Domain OCT
|
Evaluation of Obstructive Sleep Apnea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
obstructive upper airways in sleep disordered
Time Frame: 8 hours
|
The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.
|
8 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jun Zhang, PhD, UCI Beckman Laser Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20118075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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