| CTRI Number |
CTRI/2025/01/079283 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [It is a scale based comparative study ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Impact of Sleep Deprivation on Cognitive Abilities and Reaction Time in Healthy Adults |
|
Scientific Title of Study
|
Effect of sleep deprivation on cognitive function and reaction
time in healthy 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 |
Diksha Bharti |
| Designation |
Student |
| Affiliation |
Department Of Physiotherapy, Amity Institute Of Health Allied Sciences, Amity University |
| Address |
Department of physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Amity Rd, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
6203011622 |
| Fax |
|
| Email |
bhartidiksha1507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Physiotherapy, Amity Institute Of Health Allied Sciences, Amity University |
| Address |
Department of physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Amity Rd, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9717281491 |
| Fax |
|
| Email |
mgupta9@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Diksha Bharti |
| Designation |
student |
| Affiliation |
Department Of Physiotherapy, Amity Institute Of Health Allied Sciences, Amity University |
| Address |
Department of physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Amity Rd, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
6203011622 |
| Fax |
|
| Email |
bhartidiksha1507@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amity institute of health allied sciences, Amity University, amity road, Noida sector -125, Uttar Pradesh, 201301 |
|
|
Primary Sponsor
|
| Name |
Diksha Bharti |
| Address |
Amity University, amity road, Noida sector -125, Uttar Pradesh, 201301 |
| 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 |
| DrDiksha Bharti |
Amity university, Noida, Uttar Pradesh |
Department of physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Amity Rd, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
6203011622
bhartidiksha1507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee, Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults age ranged from 20 years to 45 years of age amongst whom further study will be done, based on determining whether they have sleep deprivation or have normal sleeping pattern |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brief cognitive rating scale (BCRS) |
Using BCRS Scale we will compare the cognitive function amongst the two groups specified as sleep deprived and one having normal sleeping pattern. |
| Comparator Agent |
Continuous Performance test |
To assess reaction time amongst the two groups specified as sleep deprived and one having normal sleeping pattern. |
| Comparator Agent |
General practitioner assessment of cognition (GPCOG) Screening test |
GPCOG Screening test will also compare the cognitive function amongst the two groups specified as sleep deprived and one having normal sleeping pattern. |
| Intervention |
Pittsburgh Sleep Quality Index (PSQI) |
We will assess sleep deprivation using Pittsburgh Sleep Quality Index (PSQI) scale and will divide the selected participants among two groups
Group A: Healthy adults having normal sleep pattern
Group B: Healthy adults having sleep deprivation
Duration : 4 Weeks |
| Comparator Agent |
Ruler drop test |
To assess reaction time amongst the two groups specified as sleep deprived and one having normal sleeping pattern. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 20 to 45 years
Gender male and female both
College students
IT Sector employee
Working adults |
|
| ExclusionCriteria |
| Details |
History of medical illness especially neurological diseases
sleep disorders such as
insomnia or narcolepsy
sleep apnea
History of thyroid
hypertension
type-2 diabetes
Any History of psychiatric disturbances (such as anxiety depression)
On daily dose of medication concerning above mentioned health problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive function
Using Brief cognitive rating scale (BCRS) and General practitioner assessment of cognition (GPCOG) Screening test
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reaction time
Using ruler drop test & continuous performance test |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
28/01/2025 |
| 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="0"
Months="5"
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 cross sectional study aims to determine the effect of sleep deprivation on cognitive function and reaction time in healthy adult population. After assessing sleep deprivation using Pittsburgh Sleep Quality index (PSQI), the participants will be divided into two groups: Group A including individuals having normal sleep pattern and Group B having individuals who are sleep deprived. Later in the study, cognitive function will be assessed in both the groups using brief cognitive rating scale (BCRS) and general practitioner assessment of cognition (GPCOG) Screening test. The reaction time in both the groups will be assessed using ruler drop test and continuous performance test. for data analysis, all the collected data will be transferred to the datasheet and SPSS and Microsoft excel will be used for concluding the results using independent sample t-test. |