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CBCT is considered an innovative imaging modality that can view the upper respiratory airway anatomy in a 3D manner. Recent studies tried to evaluate the accuracy of CBCT in analyzing the upper respiratory airway and its related structures. Although, most of these studies aimed to evaluate the 3D imaging of upper respiratory airway in OSA patients and their healthy counterparts, the determination of its level of collapse with the aid of CBCT wasn't clearly evaluated.
DISE is considered a dynamic approach to determine the level of upper respiratory airway collapse accurately, but CBCT can offer better evaluation of anatomical upper respiratory airway characteristics and morphology which in turn affects treatment planning and patients' satisfaction after surgery. The hypothesis is agreed with other studies who found that retroglossal collapse appears more frequently during the end of expiration imaged by dynamic MRI.
Our hypothesis is the validity of CBCT in determining the level of collapse through assessing different orthogonal planes at end of inspiration and expiration especially in those patients having a tongue/palate interaction or lengthy palate where this anatomical variation wasn't been probably evaluated with DISE.
In this validity two-arm study, a total (n) patients will be included; all are diagnosed with OSA and will undergo surgical treatment after appropriate planning. Patients will be classified into two equal groups with allocation ratio (1:1). Patients of the study group will be examined after scanning with CBCT at both ends of expiration and inspiration and DISE. Control group patients will be examined by DISE only. After discussing the treatment plan with the patient and educating the patient with all the data needed, an arabic consent form will be signed by the willing participants.
These (n) patients will be selected by the ENT specialist according to the following;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | CBCT and DISE |
| |
| Control Group | DISE only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBCT | Radiation | Cone Beam Computed Tomography |
| |
| DISE |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical improvement | through Mean Apnea/Hypoapnea Index (AHI) reduction percentage by Polysomnography (PSG) (sleep study) | 3 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Collapse of the upper respiratory airway | through LwPTL Classification | immediately after performing both DISE and CBCT |
| The volume of the upper respiratory airway. | through CBCT images (Invivo5 software) |
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Inclusion Criteria:
Exclusion Criteria:
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Obstructive Sleep Apnea Patients Indicated for Surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Isaac | Contact | +201223775262 | marco.shawky@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Marco Isaac | Cairo University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30993741 | Result | Pang KP, Baptista PM, Olszewska E, Braverman I, Carrasco-Llatas M, Kishore S, Chandra S, Yang HC, Wang CMZ, Chan YH, Pang KA, Pang EB, Rotenberg B. Does drug-induced sleep endoscopy affect surgical outcome? A multicenter study of 326 obstructive sleep apnea patients. Laryngoscope. 2020 Feb;130(2):551-555. doi: 10.1002/lary.27987. Epub 2019 Apr 17. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 22, 2021 | Jan 22, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Procedure |
Drug Induced Sleep Endoscopy |
|
| through study completion, an average of 1 year |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |