| CTRI Number |
CTRI/2021/09/036851 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSESSMENT OF SLEEP QUALITY AND ASSOCIATED FACTORS AMONG DIABETES MELLITUS PATIENTS |
|
Scientific Title of Study
|
A CROSS-SECTIONAL STUDY ON ASSESSMENT OF SLEEP QUALITY AND ASSOCIATED FACTORS AMONG DIABETES MELLITUS PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Pavan |
| Designation |
PG Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University) |
| Address |
Department of Pharmacy Practice
Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7406191088 |
| Fax |
|
| Email |
pavanskanchan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay B C |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University) |
| Address |
Department of Pharmacy Practice,
Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7975128828 |
| Fax |
|
| Email |
vinaybc2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chethan Subramanya |
| Designation |
Assistant Professor |
| Affiliation |
Justice K S Hegde Charitable Hospital (Nitte Deemed to be University) |
| Address |
Department of General Medicine
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8762552454 |
| Fax |
|
| Email |
chethansub@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Self and Justice K S Hegde Charitable Hospital Deralakatte |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of pharmacy practice NGSM Institute of Pharmaceutical Sciences |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Mr Pavan |
Department of Genaral Medicine |
Justice K S Hegde Charitable Hospital Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
74106191088
pavanskanchan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Both inpatients and outpatients of 18 years and above with past medical history of diabetes mellitus will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to be involved in the research will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will give detailed information regarding the sleep quality in diabetes mellitus patients. |
Single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will give detailed information regarding the sleep quality and its associated factors in diabetes mellitus patients. |
Single point |
|
|
Target Sample Size
|
Total Sample Size="356"
Sample Size from India="356"
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)
|
27/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/09/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross-sectional study that will be conducted to assess the sleep quality and associated factors among diabetes mellitus patients using Pittsburgh Sleep Quality Index (PSQI) and other questionnaires. In this study, we will enroll 356 diabetes mellitus patients. With the data collected using SPSS software version 20.0 data is interpreted. This study will give detailed information regarding sleep quality and its associated factors in diabetes mellitus patients. |