OSAOSANCT04874727
Comparison of Standing Versus Supine 3D Cone Beam Computed Tomography in Patient With Obstructive Sleep Apnea
An observational study of OSA and Sleep Apnea, run by Manhattan Beach Orthodontics at 1 site in United States.
Trial summary
The anatomical changes of the upper airway in a standing vs pseudo-supine position using Carestream Orthodontic Imaging (Volumetric) and Carestream Orthodontic Imaging module (AP measurements) of the patient's airway respectively, have been taken and the obtained results compared. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- OSA, Sleep Apnea
- What is being tested?
- Mandible slacked and captured with Correct Plus™ Impression Material Superfast
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population was selected from the patient pool of Dr. Maryam Bakhtiyari. They are individuals with diagnoses of OSA and consented to taking two x-rays and enrolling into this study.
Who may be able to join
- Participant must be a patient of Dr. Maryam Bakhtiyari's orthodontic practice
- Participant must have a diagnosis of obstructive sleep apnea
- Participant must have an invitation to join research study from Dr. Bakhtiyari
Who cannot join
- Participant cannot have a history of serious dental trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Beach Orthodontics
Manhattan Beach, California, 90266
About this study
Official title: Reduction of Volumetric and AP Measurements of the Airway in Pseudo-sleep Supine Position vs Standard 3D Cone Beam Computed Tomography on Patients With Sleep Apnea
The anatomical changes of the upper airway in a standing vs pseudo-supine position using Carestream Orthodontic Imaging (Volumetric) and Carestream Orthodontic Imaging module (AP measurements) of the patient's airway respectively, have been taken and the obtained results compared. In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.
- Conditions
- OSA, Sleep Apnea
- Being tested
- Mandible slacked and captured with Correct Plus™ Impression Material Superfast
- Keywords
- tomography, CBCT, Cone-beam computerized tomography, obstructive sleep apnea, airway volume, anterior-posterior measurement
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandible slacked and captured with Correct Plus™ Impression Material SuperfastProcedure or surgery
In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | The five or six individual patients enrolled are the members of the sole group, the study population. These individuals all have been diagnosed with obstructive sleep apnea and have take a Cone-beam CT scan with and without the new bite technique. Receives: Procedure: Mandible slacked and captured with Correct Plus™ Impression Material Superfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D volumetric airway measurement
Investigators will measure and compare the 3D volumetric airway of the x-ray both with and without the pseudo-supine technique. This will be done on the computer using Carestream Orthodontic Imaging.
Measured: through study completion, an average of 1 year
2D Anterior-Posterior airway Measurement
Investigators will measure and compare the 2D anterior-posterior airway of the x-ray both with and without the pseudo-supine technique. This will be done on the computer using the Carestream Orthodontic Imaging module.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Beach Orthodontics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Maryam Bakhtiyari, Manhattan Beach Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874727
- Sponsor's protocol ID
- 0002
- Acronym
- OSA
- Status last verified
- Apr 2021
- First submitted
- 18 Jan 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Volumetric and AP Measurements of the Airway in Pseudo-sleep Supine Position vs Standard 3D Cone Beam Computed Tomography on Patients With Sleep Apnea
- ClinicalTrials.gov ID
- NCT04874727
- Acronym / sponsor ID
- OSA / 0002
- Conditions
- OSA, Sleep Apnea
- Keywords
- tomography, CBCT, Cone-beam computerized tomography, obstructive sleep apnea, airway volume, anterior-posterior measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Manhattan Beach OrthodonticsUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 May 2021 (actual)
- 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 anatomical changes of the upper airway in a standing vs pseudo-supine position using Carestream Orthodontic Imaging (Volumetric) and Carestream Orthodontic Imaging module (AP measurements) of the patient's airway respectively, have been taken and the obtained results compared. In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Procedure: Mandible slacked and captured with Correct Plus™ Impression Material SuperfastThe five or six individual patients enrolled are the members of the sole group, the study population. These individuals all have been diagnosed with obstructive sleep apnea and have take a Cone-beam CT scan with and without the new bite technique. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was selected from the patient pool of Dr. Maryam Bakhtiyari. They are individuals with diagnoses of OSA and consented to taking two x-rays and enrolling into this study.
Key inclusion criteria (3 listed)
- Participant must be a patient of Dr. Maryam Bakhtiyari's orthodontic practice
- Participant must have a diagnosis of obstructive sleep apnea
- Participant must have an invitation to join research study from Dr. Bakhtiyari
Key exclusion criteria (1 listed)
- Participant cannot have a history of serious dental trauma
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 |
|---|---|---|
| Mandible slacked and captured with Correct Plus™ Impression Material SuperfastIn order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material. | Procedure or surgery | Study Population |
Primary outcome
3D volumetric airway measurement
Time frame: through study completion, an average of 1 year
Investigators will measure and compare the 3D volumetric airway of the x-ray both with and without the pseudo-supine technique. This will be done on the computer using Carestream Orthodontic Imaging.
2D Anterior-Posterior airway Measurement
Time frame: through study completion, an average of 1 year
Investigators will measure and compare the 2D anterior-posterior airway of the x-ray both with and without the pseudo-supine technique. This will be done on the computer using the Carestream Orthodontic Imaging module.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA and Sleep Apnea, run by Manhattan Beach Orthodontics at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
3D volumetric airway measurement (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 6 May 2021.