| CTRI Number |
CTRI/2025/10/096169 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of analysis of blood oxygen saturation level for the diagnosis of obstructive sleep apnea and its relation with heart disease risk in Indian subjects |
|
Scientific Title of Study
|
Application of non-linear analysis of oxygen saturation for the diagnosis of obstructive sleep apnoea and its correlation with cardiovascular risk in Indian subjects |
| 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 |
Department of Pulmonary, critical care and Sleep Medicine, Room no. 2, Porta Cabin, 3rd floor, NPW, AIIMS, Delhi
South
DELHI
110029
India |
| Phone |
09999144116 |
| 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
110029
India |
| Phone |
09999144116 |
| 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
110029
India |
| Phone |
09999144116 |
| Fax |
|
| Email |
saurabh_kgmu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| AIIMS, New Delhi, India: 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Saurabh Mittal |
| Address |
Room no. 2, Porta cabin, 3rd floor, new pvt ward, AIIMS New Delhi: 110029 |
| Type of Sponsor |
Other [Assistant Professor, Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi] |
|
|
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 |
| Saurabh Mittal |
All India Institute of Medical Sciences, New Delhi |
Department of Pulmonary, Critical care and Sleep Medicine, Room no.2, Porta cabin, Third floor, New pvt ward, Ansari Nagar, Delhi, India-110029
South
DELHI |
9999144116
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G473||Sleep apnea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
None |
None |
| Comparator Agent |
None |
None |
|
|
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
4. BMI more than 23 kg/ m2
|
|
| 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. 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 derive and validate the use of non-linear analysis in the Indian overweight/obese population in detecting OSA
a. To retrospectively apply non-linear analysis to 200 historic sleep studies
b. To determine a cut-off that can be used to predict OSA
c. Prospectively validate the use of non-linear analysis in 200 prospective patients
|
At Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2) To determine if non-linear analysis can also predict cardiovascular risk in an overweight/obese Indian population with SDB (OSA) |
At Baseline only |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/10/2025 |
| 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="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
|
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.
The use of simpler and cheaper equipment to do this would help
countries (including India) where resources are stretched, to test more
individuals and enable screening of at risk individuals (i.e. those that are
overweight and obese). Furthermore, the development of novel metrics that
capture the complexity of physiological signals will enable cardiovascular risk
stratification such that treatment can be targeted appropriately in high-risk
individuals.
Most of the work done thus
far with regards to hypoxic burden has been mainly in a Caucasian population,
with the relevance in an Indian population less known. |