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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 January 2013 |
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Main ID: |
NCT01485497 |
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Date of registration:
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02/08/2011 |
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Primary sponsor: |
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Public title:
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Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
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Scientific title:
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Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT) |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01485497 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Jun Zhang, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCI Beckman Laser Institute |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstructive Sleep Apnea)
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Intervention(s)
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Device: Evaluation of Obstructive Sleep Apnea
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Primary Outcome(s)
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obstructive upper airways in sleep disordered
[Time Frame: 8 hours]
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Secondary ID(s)
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NIH1K25HL102055 - 01A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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