| CTRI Number |
CTRI/2023/11/059931 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
10/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of sleep disturbances in HIV patients and its effect on life quality |
|
Scientific Title of Study
|
Assessment of sleep disturbances among people living with HIV and its impact on quality of life
|
| 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 ASHISH KUMAR |
| Designation |
DOCTOR (POST GRADUATE RESIDENT) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of medicine, first floor, BL taneja block, maulana azad medical college and lok nayak hospital, new delhi
Central
DELHI
110002
India |
| Phone |
8130695518 |
| Fax |
|
| Email |
nayakashish6702@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S. Anuradha |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of medicine, first floor, BL taneja block, maulana azad medical college and lok nayak hospital, new delhi
Central
DELHI
110002
India |
| Phone |
8130695518 |
| Fax |
|
| Email |
drsanuradha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHISH KUMAR |
| Designation |
DOCTOR (POST GRADUATE RESIDENT) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of medicine, first floor, BL taneja block, maulana azad medical college and lok nayak hospital, new delhi
DELHI
110002
India |
| Phone |
8130695518 |
| Fax |
|
| Email |
nayakashish6702@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of medicine, first floor, BL taneja block, maulana azad medical college and lok nayak hospital, new delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Medicine, BL Taneja Block, Maulana Azad Medical College |
| 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 Ashish |
Maulana Azad Medical College |
Room no. 618, ART center, 6th floor, OPD Block,Maulana Azad Medical
College and Lok Nayak
Hospital,2 Bahadur
Shah Zafar Marg, New
Delhi
Central DELHI
Central
DELHI |
8130695518
nayakashish6702@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. PLHIV more than 18 years of age
2. Subjects willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Night shift workers
3. Subjects with severe disability such as neurological disorder that are an impediment to
participation in study
4. Patients with severe systemic illness
5. Active ongoing opportunistic infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of sleep disturbances among PLHIV |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk factors for sleep disturbances among PLHIV |
1 year |
| Effect of sleep disturbances on QOL (Quality of life) |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/11/2023 |
| 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
|
PLHIV are at increased risk developing non-HIV related comorbidities. Among these, sleep disturbances have been one of the less studied comorbidities. Nearly 61% of PLHIV had sleeping difficulties as compared to 10% among the general population. Sleep disturbances Iead to depression and poorer life quality etc. There is a paucity of published data describing sleep disturbances and factors affecting sleep among PLHIV from India. The impact of sleep quality on the QOL of PLHIV has also not been studied. |