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CTRI Number  CTRI/2022/07/044431 [Registered on: 28/07/2022] Trial Registered Prospectively
Last Modified On: 08/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   To examine upper breathing route in people suffering from sleep related breathing disorders using sonography. 
Scientific Title of Study   Ultrasonographic assessment of upper airway dimensions in patients with obstructive sleep apnea syndrome- an observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Paul Moses 
Designation  Junior Resident 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9944725512  
Fax    
Email  abhishekmoses@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Komal Anil Gandhi 
Designation  Associate Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087003376  
Fax    
Email  dr.komalgandhi@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Komal Anil Gandhi 
Designation  Associate Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087003376  
Fax    
Email  dr.komalgandhi@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh, 160012 
 
Primary Sponsor  
Name  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh, 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Paul Moses  Nehru hospital extension block  ENT operation theatre and preoperative area, Nehru hospital extension block, PGIMER, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 9944725512

abhishekmoses@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G473||Sleep apnea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Diagnosed OSA patients (as scheduled for DISE procedure),
2. American Society of Anaesthesiologists physical status (ASA-PS) I and II,
3. Between 18-65 years of age of either gender. 
 
ExclusionCriteria 
Details  1. Patient’s refusal;
2. Inability to perform maneuvers as per study protocol;
3. History of syndromic craniofacial abnormalities (e.g., Down syndrome);
4. Burns, trauma or radiotherapy involving the head and neck region;
5. Limited neck movements;
6. Prior upper airway surgery;
7. Upper airway masses/tumors; or
8. Neuromuscular disorders other than OSA. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess percentage change in the retropalatal diameter during Muller’s maneuver for predicting severe OSA.  Baseline (pre drug induced sleep endoscopy procedure) 
 
Secondary Outcome  
Outcome  TimePoints 
-To assess
1. Percentage change in the tongue base thickness during Muller’s manoeuvre,
2. Tongue thickness/oral cavity height ratio,
3. Hyomental distance ratio,
for predicting the severity of OSA. 		 Baseline (pre drug induced sleep endoscopy procedure) 
-To correlate the dynamic airway ultrasound findings with the corresponding anatomical level findings in DISE  Baseline ultrasonography and DISE findings at the end of DISE procedure 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Now-a-days, airway ultrasonography (USG) is commonly used as a screening tool owing to wide availability, less expensive, portable, radiation free, and comfortable for patients. Submental USG has been studied as a dynamic, safe method, permitting the noninvasive visualization of soft-tissue structures of airway. we plan to conduct the prospective observational trial to evaluate the anatomic features and the dynamic changes of pharyngeal airspace by submental USG to identify OSA severity. We also plan to study the correlation between USG findings with DISE findings. The primary aim of the study is to assess percentage change in retropalatal diameter during Muller’s maneuver for predicting severe OSA in adults.  
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