| CTRI Number |
CTRI/2026/03/105650 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of heart disease risk by using a calculated score among participants with sleep-related breathing
disorder |
|
Scientific Title of Study
|
Evaluation of cardiovascular risk in patients with obstructive sleep apnea using framingham risk score at a tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Kumawat |
| Designation |
M.Sc Student |
| Affiliation |
RUHS College of Medical Sciences, Jaipur |
| Address |
Department of biochemistry RUHS College of Medical Sciences
Jaipur
RAJASTHAN
3032033
India |
| Phone |
8955480210 |
| Fax |
|
| Email |
kumawatdivya1309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Sharma |
| Designation |
Senior Professor |
| Affiliation |
RUHS College of Medical Sciences Jaipur |
| Address |
Department of biochemistry RUHS college of Medical Sciences
Jaipur
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
sonalisharma14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Kumawat |
| Designation |
M.Sc Student |
| Affiliation |
RUHS College of Medical Sciences Jaipur |
| Address |
Department of biochemistry RUHS College of Medical Sciences
Jaipur
RAJASTHAN
302033
India |
| Phone |
8955480210 |
| Fax |
|
| Email |
kumawatdivya1309@gmail.com |
|
|
Source of Monetary or Material Support
|
| RDBP Jaipuria Hospital, Indra Nagar, Basant Vihar, Milap Nagar, Jaipur, Rajasthan 302018 |
| RUHS College of Medical Sciences, sector 11, kumbha Marg, Pratap Nagar, Jaipur, Rajasthan 302033 India |
|
|
Primary Sponsor
|
| Name |
Divya Kumawat |
| Address |
Khejada Wali Dhani Alisar Chomu, Jaipur, Pincode 303801, Rajasthan, 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 |
| Divya Kumawat |
RUHS College of Medical Sciences |
Khejada Wali Dhani, alisar, chomu, Jaipur, Rajasthan
RUHS College of Medical Sciences
Jaipur
RAJASTHAN |
8955480210
kumawatdivya1309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS-CMS Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirm diagnosis of obstructive sleep apnea (OSA) by polysomnography.
2.Those who give informed consent.
|
|
| ExclusionCriteria |
| Details |
1.History of any physician diagnosed CVD, such as MI, valvular heart disease and Coronary artery diseases (CAD)
2.Psychiatric disease.
3.Known central sleep apnea
4.Medication that may influence consciousness level and circadian rhythm.
5.Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the 10-year cardiovascular risk in patients diagnosed with obstructive sleep apnea by applying the
Framingham Risk Score.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the cardiovascular risk profiles of OSA patients with different severity levels (mild, moderate, severe).
2. To identify cardiovascular risk factors that are most prevalent in the OSA patient population.
3. To evaluate the relationship between OSA severity (as measured by the Apnea-Hypopnea Index) and the calculated Framingham Risk Score.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
16/03/2026 |
| 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="6"
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
|
This study evaluates the heart disease risk in patients with Obstructive Sleep Apnea (OSA) using the Framingham Risk Score. It examines how OSA severity relates to cardiovascular problems. The findings will help in early detection and better management of heart risk in OSA patients. |