Sleep ApneaPhase 1NCT01485497
Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
A Phase 1 study testing 3D endoscopic Fourier Domain OCT in people with Sleep Apnea, run by University of California, Irvine.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- 3D endoscopic Fourier Domain OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea
- Being tested
- 3D endoscopic Fourier Domain OCT
- Keywords
- APNEA
- Medical subject headings
- Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D endoscopic Fourier Domain OCTDevice
Evaluation of Obstructive Sleep Apnea
| Study group | Role | What they receive |
|---|---|---|
| 3D endoscopic Fourier Domain OCT | Other | 3D endoscopic Fourier Domain OCT Receives: Device: 3D endoscopic Fourier Domain OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
obstructive upper airways in sleep disordered
The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- VA Long Beach Healthcare System, Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Jun Zhang, PhD, Principal investigator, UCI Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485497
- Sponsor's protocol ID
- 20118075
- Status last verified
- Oct 2022
- First submitted
- 2 Aug 2011
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
- ClinicalTrials.gov ID
- NCT01485497
- Acronym / sponsor ID
- 20118075
- Conditions
- Sleep Apnea
- Keywords
- APNEA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- VA Long Beach Healthcare System, Beckman Laser Institute University of California Irvine
- Study start
- May 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D endoscopic Fourier Domain OCT | Other | Device: 3D endoscopic Fourier Domain OCT3D endoscopic Fourier Domain OCT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D endoscopic Fourier Domain OCTEvaluation of Obstructive Sleep Apnea | Device | 3D endoscopic Fourier Domain OCT |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, PhD principal investigator
UCI Beckman Laser Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3D endoscopic Fourier Domain OCT in people with Sleep Apnea, run by University of California, Irvine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obstructive upper airways in sleep disordered (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.