Evaluation of Post-surgical Improvement in OSA Patients After Imaging of Upper Airway Using CBCT and DISE vs DISE Only

NCT04727346 | Unknown

• 1 other identifier: OCS05051989
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

CBCT, OSA, DISE

Outcome Measures

Primary Outcomes (1)

• Post-surgical improvement

  through Mean Apnea/Hypoapnea Index (AHI) reduction percentage by Polysomnography (PSG) (sleep study)

  3 months after the surgery

Secondary Outcomes (2)

• Level of Collapse of the upper respiratory airway

  immediately after performing both DISE and CBCT

• The volume of the upper respiratory airway.

  through study completion, an average of 1 year

Study Arms (2)

Study Group

CBCT and DISE

Radiation: CBCT; Procedure: DISE

Control Group

DISE only

Procedure: DISE

Interventions

CBCT RADIATION

Cone Beam Computed Tomography

Study Group

DISE PROCEDURE

Drug Induced Sleep Endoscopy

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obstructive Sleep Apnea Patients Indicated for Surgery

You may qualify if:

• Patients' age is more than 18 years old.
• Patients are indicated for upper respiratory airway surgery based on adequate history taking, proper clinical examination, and sleep study.
• Patients refusing Continuous Positive Airway Pressure (CPAP) treatment.
• Systemically medically free patients.

You may not qualify if:

• Patients who are refusing the surgical approach as a treatment plan option.
• Patients who have undergone previous surgeries in the upper respiratory airway.
• Pregnant women.
• Patients who didn't follow post-operative instructions.
• Patients who are not able to come for the follow-up appointments.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 30993741 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Marco Isaac

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Isaac

CONTACT

+201223775262; marco.shawky@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2021
• Primary Completion: May 22, 2022
• Study Completion: July 22, 2022
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share