| CTRI Number |
CTRI/2025/07/090437 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Risk of Obstructive Sleep Apnea and its association with BMI , Neck circumference etc
in Young Adults in Urban Population - An Analytical
study. |
|
Scientific Title of Study
|
Prevalence of Risk of Obstructive Sleep Apnea and its association with
Anthropometric Parameters in Young Adults in Urban Population - An Analytical
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 |
Dr Shreya Dhake |
| Designation |
HOD and Asso. professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy , DE Societys Brijlal Jindal College of Physiotherapy ,Fergusson College Campus,Shivaji nagar
Pune MAHARASHTRA 411004 India |
| Phone |
9892252731 |
| Fax |
|
| Email |
shreya.dhake@despune.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shashwati Kamble PT |
| Designation |
Postgraduate student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
DE Societys Brijlal Jindal College of Physiotherapy ,Fergusson College Campus Shivaji nagar ,Pune
Pune MAHARASHTRA 411004 India |
| Phone |
7448087060 |
| Fax |
|
| Email |
shashwatikamble@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shashwati Kamble PT |
| Designation |
Postgraduate student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
DE Societys Brijlal Jindal College of Physiotherapy ,Fergusson College Campus Shivaji nagar ,Pune
Pune MAHARASHTRA 411004 India |
| Phone |
7448087060 |
| Fax |
|
| Email |
shashwatikamble@gmail.com |
|
|
Source of Monetary or Material Support
|
| DE Societys Brijlal Jindal College of Physiotherapy , Fergusson College Campus , Pune 411004 India . |
|
|
Primary Sponsor
|
| Name |
Shashwati Kamble |
| Address |
DE Societys Brijlal Jindal College of Physiotherapy , Fergusson College Campus , Pune 411004 India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrShashwati Kamble |
DE Societys Brijlal Jindal College of Physiotherapy , Fergusson College Campus , Pune |
DE Societys Brijlal Jindal College of Physiotherapy , Fergusson College Campus ,Shivaji nagar Pune 411004 India. Pune MAHARASHTRA |
7448087060
shashwatikamble@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DE Societys Brijlal Jindal College of Physiotherapy ,Institutional Ethics Committee Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy young adults aged 18 to 30 years
Males and Females both |
|
| ExclusionCriteria |
| Details |
Pregnancy in 2nd and 3rd trimester
Individuals diagnosed with OSA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.STOP-BANG SCORE
2.BMI
3.NECK CIRCUMFERENCE
4.WAIST CIRCUMFERENCE
5.WC-TO-HEIGHT RATIO (WHr)
6.NC-TO-HEIGHT RATIO (NHr)
7.BODY FAT PERCENTAGE
VISCERAL FAT RATING |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="152" Sample Size from India="152"
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)
|
20/07/2025 |
| 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
|
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder leading to sleepiness, drowsiness, decreased alertness, and poor concentration. The prevalence of OSA ranges from 4.4% to 13.7% in young adults in India. OSA is increasingly recognized as a significant health concern. While OSA is traditionally considered a condition that primarily affects older adults, there is growing recognition that it also significantly impacts younger individuals, including adolescents and young adults. The consequences of undiagnosed and untreated OSA in this age group may be far-reaching, potentially affecting cognitive function, academic performance, mood regulation, and overall quality of life. In this study the risk of Obstructive sleep Apnea will be assessed with the help of Stop bang questionnaire which is validated questionnaire and anthropometric parameters which are BMI , neck circumference , waist circumference , WC-to-height ratio (WHr)-,NC-to-height ratio (NHr)-,(Body fat analyzer )body fat percentage, visceral fat rating , 152 healthy individuals will be taken in which there will be76 male and 76 female . The association will be established using Pearson’s correlation / Spearman’s correlation depending on the normality of the data . The conclusion will be find out . |