Comparison of Standing Versus Supine 3D Cone Beam Computed Tomography in Patient With Obstructive 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.

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Key information

Conditions

OSA Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Manhattan Beach Orthodontics

Manhattan Beach, California, 90266, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Participant cannot have a history of serious dental trauma

Treatment and study plan

Mandible slacked and captured with Correct Plus™ Impression Material Superfast

Procedure

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Manhattan Beach Orthodontics

Other

Registry information

Official study 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

Acronym: OSA

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: May 6, 2021
Registry last updated: May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed