| CTRI Number |
CTRI/2025/08/092892 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sleep Hygiene and Your Heart: A Study on Adults Health |
|
Scientific Title of Study
|
Effect of sleep hygiene on cardio-metabolic health among the adult population. |
| 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 Rishabh Kothari |
| Designation |
Junior resident |
| Affiliation |
Datta meghe institue of higher education and research. |
| Address |
Flat f-2, meghe heights 2, jnmc campus, sawangi, wardha, maharashtra, 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9887157587 |
| Fax |
|
| Email |
Rishabhkothari732@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Choudhari |
| Designation |
Professor, department of community medicine. |
| Affiliation |
Datta meghe institue of higher education and research. |
| Address |
Jawaharlal nehru medical college, datta meghe institute of higher education and research, sawangi, wardha, maharashtra, 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8600647967 |
| Fax |
|
| Email |
cdrsonali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Choudhari |
| Designation |
Professor, department of community medicine. |
| Affiliation |
Datta meghe institue of higher education and research. |
| Address |
Jawaharlal nehru medical college, datta meghe institute of higher education and research, sawangi, wardha, maharashtra, 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8600647967 |
| Fax |
|
| Email |
cdrsonali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta meghe institute of higher education and research, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta meghe institute of higher education and research |
| Address |
Sawangi, wardha, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Rishabh Kothari |
AVB Rural Hospital |
Department of Community Medicine/Rural field area under hospital/Jawaharlal Nehru Medical College
Wardha
MAHARASHTRA |
9887157587
Rishabhkothari732@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, datta meghe institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult population for general examination to find sleep disturbance and presence of metabolic syndrome. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult population residing in the area of study and provides consent for the study. |
|
| ExclusionCriteria |
| Details |
Current use of sleep medications, known diagnosis of sleep disorders, existing severe morbid conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of poor sleep quality, prevalence of cardiometabolic risk factors, association between poor sleep hygiene and cardiometabolic risk factors, prevalence of metabolic syndrome. |
Single point study |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="281"
Sample Size from India="281"
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)
|
01/09/2025 |
| 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="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 research investigates the link between sleep quality and cardio-metabolic health in the rural Indian population. It aims to determine the prevalence of both poor sleep and cardio-metabolic risk factors, and then analyze the association between them. The study will use the Pittsburgh Sleep Quality Index to assess sleep quality and identify potential connections to health issues like hypertension and diabetes. |