| CTRI Number |
CTRI/2025/08/093619 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
"How Poor Sleep Affects Brain Function and Stress Levels in Sleep-Deprived People Compared to Those with Good Sleep" |
|
Scientific Title of Study
|
Effect of Sleep Quality on P300 and Oxidative Stress in Sleep Deprived as compared to controls. |
| 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 Maddi Poojitha Reddy |
| Designation |
Junior Resident 1 ( Post Graduate) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology, Second Floor, Pathology Block, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9059104822 |
| Fax |
|
| Email |
pooji245@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Swami |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9999000993 |
| Fax |
|
| Email |
swamidoctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maddi Poojitha Reddy |
| Designation |
Junior Resident 1 ( Post Graduate) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology, Second Floor, Pathology Block, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9059104822 |
| Fax |
|
| Email |
pooji245@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated hospitals, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Dr Maddi Poojitha Reddy |
| Address |
Department of Physiology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi, 110002 |
| 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 |
| Dr Maddi Poojitha Reddy |
Maulana Azad Medical College and associated Hospitals |
Second Floor, Department of Physiology, Maulana Azad Medical College, New Delhi
Central
DELHI |
9029104822
pooji245@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep Deprived |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Those subjects which are fulfilling the criteria of Pittsburgh Sleep Quality Index scale (PSQI).
2. Age between 20 to 40 years.
|
|
| ExclusionCriteria |
| Details |
(a) Diagnosed cases of hepatic, renal, cardiac diseases, diabetes mellitus, cancer and systemic inflammatory disorders.
(b) Diagnosed cases of seizure disorders, learning disabilities, autism, mental retardation, and other psychotic disorders.
(c) Presence of any significant visual or hearing impairment.
(d) Subjects with history of tobacco consumption and/or alcohol consumption.
(e) Subjects on antipsychotic drugs, sedatives.
(f) Subjects on medications which alter GSH and MDA levels.
(g) Subjects on anti-oxidants such as Vitamin C, Vitamin E, Ashwagandha.
(h) Subjects on Glutathione supplements for skin brightening.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find association & correlation between P300 (Latency & Amplitude) & biomarkers (Glutathione & Malondialdehyde) in sleep deprived subjects. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Latency & Amplitude of P300 in sleep deprived subjects with apparently healthy controls. |
Baseline |
| To compare the biomarkers i.e. glutathione (GSH) and malondialdehyde (MDA) in sleep deprived subjects with healthy controls. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study will be conducted in Nerve Conduction Velocity (NCV) room, Department of Physiology, Maulana Azad Medical College. The current study aims to study the effect of sleep quality on P300 & Oxidative stress in Sleep deprived as compared to controls. |