| CTRI Number |
CTRI/2025/10/095732 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Seeing Sleep Apnea Differently: A Study of Throat Anatomy Using 3D Imaging |
|
Scientific Title of Study
|
Dimensional and volumetric analysis of the oropharyngeal region in Obstructive Sleep Apnea patients using Cone Beam Computed Tomography- a case control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Jain Choudhary |
| Designation |
Reader |
| Affiliation |
Peoples College of Dental Sciences and Research Center |
| Address |
Peoples College of Dental Sciences and Research Center, Department Of Oral Medicine And Radiology, Block A, room no. G1
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
08461868282 |
| Fax |
|
| Email |
31jainaaryash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Palak Jain Choudhary |
| Designation |
Reader |
| Affiliation |
Peoples College of Dental Sciences and Research Center |
| Address |
Peoples College of Dental Sciences and Research Center, Department Of Oral Medicine And Radiology, Block A, room no. G1
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
08461868282 |
| Fax |
|
| Email |
31jainaaryash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Palak Jain Choudhary |
| Designation |
Reader |
| Affiliation |
Peoples College of Dental Sciences and Research Center |
| Address |
Peoples College of Dental Sciences and Research Center, Department Of Oral Medicine And Radiology, block A, room no. G1
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
08461868282 |
| Fax |
|
| Email |
31jainaaryash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College Of Dental Sciences And Research Center, Ayodhya Bypass Rd, A Block, Bhanpur, Bhopal, Madhya Pradesh, India, 462037 |
|
|
Primary Sponsor
|
| Name |
Dr Palak Jain Choudhary |
| Address |
Peoples College Of Dental Sciences And Research Center, Ayodhya Bypass Rd, A Block, Bhanpur, Bhopal, Madhya Pradesh, India, 462037 |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Palak Jain Choudhary |
Peoples College of Dental Sciences and Research Center |
Department Of Oral Medicine And Radiology, Block A, Room no.G1
Bhopal
MADHYA PRADESH |
08461868282
31jainaaryash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G473||Sleep apnea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-group I-Obstructive Sleep Apnea patients- patients who will undergo Cone Beam Computed Tomography for various other diagnostic reasons (e.g., temporomandibular joint problems, condylar hyperplasia, assessment of impacted and supernumerary teeth etc).
-patients with suspected symptoms of Obstructive Sleep Apnea diagnosed for it by following a standard protocol.
-Epworth Sleepiness Scale more than 10, STOP BANG more than 3, Apnea Hypopnea Index more than 5
-Participants who provide written informed consent, agreeing to participate in the study and for their data to be used for research purposes.
-Group II- non Obstructive Sleep Apnea patients
-Individuals who will undergo Cone Beam Computed Tomography for various other diagnostic reasons (e.g., temporomandibular joint problems, condylar hyperplasia, assessment of impacted and supernumerary teeth, etc.).
-Age and gender matched Participants
-No history of snoring or any respiratory disorder
-Epworth Sleepiness Scale score from 2 to 10
-A STOP-BANG questionnaire score of less than 3
-Having anatomically normal airway as seen on Cone Beam Computed Tomography scan with no radiologically evident pathology in the airway.
-No history of cleft lip and palate, post maxillofacial trauma or surgery
|
|
| ExclusionCriteria |
| Details |
•patients with heart disease
•Pregnant women radiation hazards.
•History of craniofacial anomalies or surgeries
•Neurological disorders affecting respiration
•Incomplete Cone Beam Computed Tomography data
•Individuals who have had major surgery or hospitalization within the last six months.
•Individuals who refuse to sign the consent agreement.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of oropharyngeal airway volume and Minimum cross sectional area between OSA patients and healthy controls |
at Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Differences in soft palate & tongue length |
at Baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2025 |
| Date of Study Completion (India) |
10/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This observational study aims to evaluate volumetric and dimensional differences in the oropharyngeal airway between patients with Obstructive Sleep Apnea (OSA) and healthy individuals using upright Cone Beam Computed Tomography (CBCT) scans. Twenty subjects will be divided into two groups based on Epworth Sleepiness Scale (ESS), STOP-BANG scores, and Apnea-Hypopnea Index (AHI). Key parameters assessed include oropharyngeal airway volume, minimum cross-sectional area (MCA), anteroposterior and lateral dimensions, soft palate and tongue length. The study seeks to identify anatomical markers associated with OSA to support improved diagnostic and therapeutic strategies. |