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

January 22, 2021 updated by: Marco Emad Shawky Isaac, Cairo University

Assessment of Post-surgical Improvement in Obstructive Sleep Apnea Patients After Imaging of Upper Respiratory Airway Using Cone Beam Computed Tomography (CBCT) and Drug-Induced Sleep Endoscopy (DISE) Versus Drug-Induced Sleep Endoscopy Only: A Validity Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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;

  • A multidisciplinary approach will be performed to diagnose OSA patients who are indicated for surgery. Firstly, a comprehensive assessment of patients' history will be performed; including evaluation of all risk factors and complete sleep history.
  • Epworth Sleepiness Scale (ESS) which consists of eight section questionnaire that defines the frequency of an individual to fall asleep during regular daily activities will be obtained from the patients.
  • Afterward, a proper physical examination will be performed including a thorough clinical examination of the oropharynx, nasopharynx, and hypopharynx to evaluate any anatomical abnormalities as impotency of the nasal airway, elongated soft palate or uvula, enlarged lingual tonsils, and any other pathological conditions of tongue, palate, and tonsils.
  • Then, Polysomnography (PSG) (sleep study) will be performed to allow proper evaluation of normal and abnormal physiological sleep episodes. Apnea/Hypoapnea Index (AHI) will be reported to detect the severity of OSA and patients were classified into mild (AHI = 5-14/ hour), moderate (AHI = 15-30 / hour) and severe (AHI >30 / hour).
  • All patients in both groups will undergo upper airway surgery, DISE will be performed by the same ENT surgeon to detect the level of collapse in the upper airway which will be assessed by LwPTL and VOTE classifications, emphasizing on the primary structures contributing at upper airway collapse, either alone or in combination: the larynx, palate, tongue and pharyngeal lateral walls.
  • Study group participants only will be scanned by CBCT twice; once at the end of inspiration and the other at the end of expiration while they are gently holding their breath for as long as possible.
  • In the study group, surgical procedures decision will be taken after appropriate assessment to sites of collapse in CBCT views at both ends of expiration and inspiration vies in combination to DISE.
  • Finally, strict post-operative instructions will be given to patients of both group and a 3 months follow up would be done.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Obstructive Sleep Apnea Patients Indicated for Surgery

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
CBCT and DISE
Radiation: CBCT
Cone Beam Computed Tomography
Procedure: DISE
Drug Induced Sleep Endoscopy
Control Group
DISE only
Procedure: DISE
Drug Induced Sleep Endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical improvement
Time Frame: 3 months after the surgery
through Mean Apnea/Hypoapnea Index (AHI) reduction percentage by Polysomnography (PSG) (sleep study)
3 months after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Collapse of the upper respiratory airway
Time Frame: immediately after performing both DISE and CBCT
through LwPTL Classification
immediately after performing both DISE and CBCT
The volume of the upper respiratory airway.
Time Frame: through study completion, an average of 1 year
through CBCT images (Invivo5 software)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Marco Isaac, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

May 22, 2022

Study Completion (Anticipated)

July 22, 2022

Study Registration Dates

First Submitted

January 17, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCS05051989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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