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CTRI Number  CTRI/2024/02/063091 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Diagnostic 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparative study of two new devices (based on vessel tone) for the diagnosis of obstructive sleep apnea 
Scientific Title of Study   A comparison of two peripheral arterial tonometry-based sleep devices 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, New Delhi 
Address  Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
Delhi
South
DELHI
110029
India 
Phone  01126546357  
Fax    
Email  saurabh_kgmu@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Saurabh Mittal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
Delhi

DELHI
110029
India 
Phone  01126546357  
Fax    
Email  saurabh_kgmu@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Saurabh Mittal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
Delhi

DELHI
110029
India 
Phone  01126546357  
Fax    
Email  saurabh_kgmu@yahoo.co.in  
 
Source of Monetary or Material Support  
Research section, All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Dr Saurabh Mittal 
Address  Room no. 2, Porta Cabin, Third floor, New Private ward, AIIMS, New Delhi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Anant Mohan  Room no. 5, Porta Cabin, Third floor, New Private ward, AIIMS, New Delhi 
Dr Dinu Santha Chandran  Dept of Physiology, AIIMS, New Delhi 
Dr Karan Madan  Room no. 7, Porta Cabin, Third floor, New Private ward, AIIMS, New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Saurabh Mittal  AIIMS, New delhi  Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi Delhi
South
DELHI 		 01126546357

saurabh_kgmu@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  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 
Comparator Agent  Level 1 polysomnography  Level 1 polysomnography is gold-standard for the diagnosis of sleep apnea. This will be done overnight in the hospital in sleep lab (once only, during entire night) 
Intervention  One Sleep test device  The device will be applied on patients finger overnight during sleep study in the hospital on one night(once only, during entire night) 
Comparator Agent  WatchPAT 200  WatchPAT 200 is a portable sleep study device which will be applied to patient during sleep study in sleep lab (once only, during entire night) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Study participants should be adults (18 years of age or older)
2. Participants with clinical suspicion of OSA, who are referred for a sleep study
3. 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   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the correlation of AHI as measured by One Sleep Test 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 One Sleep Test 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 OST 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  At baseline 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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 4 
Date of First Enrollment (India)   01/03/2024 
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)   Not Applicable 
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  

Rationale: The diagnosis is OSA is delayed due to late identification by the clinicians and time lost during waiting for a sleep study. Currently, the gold-standard test, a level 1 in-lab study has long waiting times in most hospitals and this has paved the way for the development of new diagnostic devices. Two such devices based on peripheral arterial tonometry principles have been developed (WatchPAT and One Sleep Test). WatchPAT has been tested in the Indian population recently by our group; however, the validation of OST with WatchPAT and PSG has not been done.

Novelty:This study will be the first of its kind to do a comparative evaluation of two PAT-based devices for OSA as compared to gold-standard level 1 PSG and assess the effect of arterial stiffness on device performance in these patients.

Objectives: To assess the correlation of Apnea-hypopnea index (AHI),  time spent below 90% saturation, and ODI (Oxygen desaturation Index) as measured by One Sleep Test as compared to that by Level 1 PSG and WatchPAT 200 for the diagnosis of OSA. We will also assess the effect of arterial stiffness on these correlations. 

Methods:We will include 99 patients with suspected OSA who are planning to undergo polysomnography in our department. After clinical evaluation, patients will undergo PSG with simultaneous recording on WatchPAT and One sleep test. All patients will undergo arterial stiffness measurement as well. The PSG will be reported as per AASM guidelines and WatchPAT and OST will have automated software-based reporting. We will analyze the correlation of AHI by OST and watchPAT along with the impact of arterial stiffness on this correlation and differences in AHI between the devices.

 
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