Obstructive Sleep ApneaNCT04727346
Evaluation of Post-surgical Improvement in OSA Patients After Imaging of Upper Airway Using CBCT and DISE vs DISE Only
An observational study of Obstructive Sleep Apnea, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CBCT and DISE
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 22 Jul 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obstructive Sleep Apnea Patients Indicated for Surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CBCT, DISE
- Keywords
- CBCT, OSA, DISE
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
Cone Beam Computed Tomography
DISEProcedure or surgery
Drug Induced Sleep Endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Study Group | CBCT and DISE Receives: Radiation: CBCT; Procedure: DISE | |
| Control Group | DISE only Receives: Procedure: DISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical improvement
through Mean Apnea/Hypoapnea Index (AHI) reduction percentage by Polysomnography (PSG) (sleep study)
Measured: 3 months after the surgery
Secondary outcomes (2)
Level of Collapse of the upper respiratory airway
through LwPTL Classification
Measured: immediately after performing both DISE and CBCT
The volume of the upper respiratory airway.
through CBCT images (Invivo5 software)
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 posted27 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion22 May 2022 (estimated)
- Study completion22 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Emad Shawky Isaac, Cairo University
- Investigators
- Marco Isaac, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727346
- Sponsor's protocol ID
- OCS05051989
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30993741
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04727346
- Acronym / sponsor ID
- OCS05051989
- Conditions
- Obstructive Sleep Apnea
- Keywords
- CBCT, OSA, DISE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 22 May 2022 (estimated)
- Study completion
- 22 Jul 2022 (estimated)
- First posted
- 27 Jan 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Radiation: CBCT, Procedure: DISECBCT and DISE |
| Control Group | – | Procedure: DISEDISE only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive Sleep Apnea Patients Indicated for Surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| CBCTCone Beam Computed Tomography | Radiation | Study Group |
| DISEDrug Induced Sleep Endoscopy | Procedure or surgery | Control Group, Study Group |
Primary outcome
Post-surgical improvement
Time frame: 3 months after the surgery
through Mean Apnea/Hypoapnea Index (AHI) reduction percentage by Polysomnography (PSG) (sleep study)
2 secondary outcomes
Level of Collapse of the upper respiratory airway
Time frame: immediately after performing both DISE and CBCT
The volume of the upper respiratory airway.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Results publication: PubMed 30993741Pang 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.
- 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.
Marco Isaac principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Cairo University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Isaac (+201223775262, marco.shawky@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical improvement (time frame: 3 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727346, which also lists 1 linked publication.
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 27 Jan 2021.