| CTRI Number |
CTRI/2021/12/038619 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
10/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of Sleep and its influencing factors among adults in Delhi |
|
Scientific Title of Study
|
Quality of Sleep and its influencing factors among adults residing in Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aswathy krishna |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi,
Central
DELHI
110002
India |
| Phone |
9400044026 |
| Fax |
|
| Email |
commedicine.aswathykrishna.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Panna Lal |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi,
Central
DELHI
110002
India |
| Phone |
9968604247 |
| Fax |
|
| Email |
dr.plal@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswathy krishna |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi,
Central
DELHI
110002
India |
| Phone |
9400044026 |
| Fax |
|
| Email |
commedicine.aswathykrishna.2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, New Delhi, 110002 |
| Type of Sponsor |
Government 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 Aswathy krishna |
Maulana Azad Medical College and associated hospitals |
Department of Community Medicine, Maulana Azad Medical College and associated hospitals, New Delhi
Central
DELHI |
9400044026
commedicine.aswathykrishna.2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
20 years and above |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.subjects aged 20yrs and above residing in the study area.
2. Subjects with no cognitive impairment. |
|
| ExclusionCriteria |
| Details |
1.subjects who are seriously ill. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality score by Pittsburgh Sleep Quality Index among adults residing in the study area |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of various factors associated with sleep quality such as socio-demographic, environmental, psychosocial comorbidities,etc
Health seeking behaviour related to sleep among study subjects |
5 months |
|
|
Target Sample Size
|
Total Sample Size="314"
Sample Size from India="314"
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)
|
15/12/2021 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a community based, cross sectional study, to know the prevalence of quality of Sleep and its influencing factors among adults aged 20 years and above residing in UHC Gokalpuri and RHTC Barwala,the field practice areas of Department of Community Medicine, Maulana Azad Medical College, New Delhi |