Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
Status and phase
Conditions
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Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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