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CTRI Number  CTRI/2025/11/097283 [Registered on: 12/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A comparison of two wearable devices for diagnosis of obstructive sleep apnea 
Scientific Title of Study   A comparison of WatchPAT and Belun ring device for the diagnosis of obstructive sleep apnea 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saurabh Mittal 
Designation  Assistant Professor, 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Department of Pulmonary, Critical Care and Sleep Medicine, Room no. 2, Porta cabin, 3rd floor, New pvt ward, AIIMS, Delhi

South
DELHI
110029
India 
Phone  9999144116  
Fax    
Email  saurabh_kgmu@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Saurabh Mittal 
Designation  Assistant Professor, Pulmonary, Critical care and Sleep Medicine 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Department of Pulmonary, Critical Care and Sleep Medicine, Room no. 2, Porta cabin, 3rd floor, New pvt ward, AIIMS, Delhi


DELHI
110029
India 
Phone  9999144116  
Fax    
Email  saurabh_kgmu@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Saurabh Mittal 
Designation  Assistant Professor, Pulmonary, Critical care and Sleep Medicine 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Department of Pulmonary, Critical Care and Sleep Medicine, Room no. 2, Porta cabin, 3rd floor, New pvt ward, AIIMS, Delhi


DELHI
110029
India 
Phone  9999144116  
Fax    
Email  saurabh_kgmu@yahoo.co.in  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  Saurabh Mittal 
Address  Room no. 2, Porta cabin, 3rd floor, New pvt ward, AIIMS, Delhi 
Type of Sponsor  Other [Assistant Professor] 
 
Details of Secondary Sponsor  
Name  Address 
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 Saurabh Mittal  All India Institute of Medical Sciences  Room no. 2, Porta cabin, 3rd floor, Department of Pulmonary, Critical care and Sleep Medicine, New pvt ward, AIIMS, Delhi
South
DELHI 		 09999144116

saurabh_kgmu@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS  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 
Intervention  Belun Ring device  Will be asked to wear for one night during sleep study 
Comparator Agent  Polysomnography  Patients will be undergoing one night sleep study in the lab 
Comparator Agent  WatchPAT device  This device will be worn by patient on the wrist during sleep study in the hospital 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Participants with clinical suspicion of OSA, who are referred for a sleep study
2. Participants should be able to understand and comply with the study procedures and requirements
 
 
ExclusionCriteria 
Details  1. Participants with a previous diagnosis of obstructive sleep apnea or receiving treatment for the same
2. Participants who are unable or unwilling to provide informed consent
3. Individuals with a history of significant psychiatric disorders or cognitive impairment that may interfere with their ability to participate or comply with the study requirements
4. Pregnant women or individuals who are breastfeeding
5. Patients with known peripheral arterial disease or any other condition that can affect the accuracy of peripheral arterial tonometry measurements
6. Inadequate data acquisition during level 1 polysomnography (less than 120 minutes of sleep time) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the correlation of AHI as measured by Belun Ring Device as compared to that by Level-1 polysomnography for the diagnosis of OSA  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the correlation of AHI as measured by Belun ring device as compared to that by WatchPAT 200 for the diagnosis of OSA  At baseline 
To assess the correlation between Time spent below 90% saturation between the two devices  At baseline 
To assess the correlation between ODI (Oxygen desaturation Index), total sleep time, and sleep efficiency between Belun ring device and WatchPAT 200  At baseline 
To assess the effect of stiffness index as measured using Artsens device on the correlation of AHI between the three devices in a subgroup of patients  At baseline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3 
Date of First Enrollment (India)   15/12/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The currently available gold-standard device for the diagnosis of OSA is in-lab PSG which requires patients to visit a sleep lab and stay overnight. However, this may be uncomfortable to many and may hamper their sleep leading to inadequate data acquisition. Newer portable devices for monitoring in home environments have been developed; however, validation in clinical settings is lacking for some of them. We recently validated one such device watchPAT 200; however, another new device Belun ring is yet to be validated in Indian subjects. The study will also explore whether having increased arterial stiffness will impact the performance of the device.

Belun ring device is an easy to use and does not have any additional costs of the device as in WatchPAT and is available just as a finger-worn ring. If this device is validated in Indian subjects, it will definitely impact the ease of conducting the sleep study and help in the early diagnosis of OSA.

 
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