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CTRI Number  CTRI/2024/03/064584 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An analytical cross-sectional study to assess the association of Nidra (Sleep quality) with Smriti (Working memory) in healthy & shift workers  
Scientific Title of Study   “Assessment of the association of Nidra (Sleep quality) with Smriti (Working memory) in healthy & shift workers – An analytical cross-sectional double-arm study’’ 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Tanuja Manoj Nesari 
Designation  Director and Head of department, Department of Kriya sharir 
Affiliation  All India Institute of Ayurveda, New delhi 
Address  Room No 002, Ground Floor, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076

South
DELHI
110076
India 
Phone  9958817145  
Fax    
Email  director@aiia.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Tanuja Manoj Nesari 
Designation  Director and Head of department, Department of Kriya sharir 
Affiliation  All India Institute of Ayurveda, New delhi 
Address  Room No 002, Ground Floor, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076
Room No 002, Ground Floor, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076

DELHI
110076
India 
Phone  9958817145  
Fax    
Email  director@aiia.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Garima Pandey 
Designation  M.D. Scholar 
Affiliation  All India Institute of Ayurveda, New delhi 
Address  Room No 312, Third Floor, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076
Room No 312, Third Floor, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076
South
DELHI
110076
India 
Phone  7055092912  
Fax    
Email  garimapandey841@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri, Sarita vihar ,New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Garima Pandey  All India Institute of Ayurveda   Room No.312, Department of Kriya sharira
South
DELHI 
7055092912

garimapandey841@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  APPERANTLY HEALTHY INDIVIDUALS SHIFT WORKERS 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Apperanly healthy individuals of the age group 25 to 45 years irrespective of gender caste and religion
2) participant should be literate
3) individuals willing to participate
4) group A- Day shift workers(working in day time for a min of 8 hrs for at least past 6 months)
5) Group B - Day night shift workers (Working at alternate day night shift min 8 hrs for 15- 30 days per month from at least past 6 months 
 
ExclusionCriteria 
Details  1) Individuals having a history of any head injury, head surgery
2) Individuals having a history of any major medical illness (HTN, DM, Parkinson’s disease, Alzheimer’s disease, etc.)
3) Individuals consuming any kind of medications, narcotics, etc. to induce sleep
4) Individuals taking any medication to enhance memory.
5) Individuals having drug and addiction (smoking) history.
6) Pregnant and lactating mothers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in working memory score will be obtained in disturbed sleep pattern
individuals. 
Decrease in working memory score will be obtained in disturbed sleep pattern
individuals. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/04/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 15-02-2025 and end date provided 28-02-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
RESEARCH QUESTION:

What is the difference in Smriti (Working memory) of shift workers following different sleep
patterns to the normal shift workers (day shift workers) following normal sleep patterns?

NULL HYPOTHESIS (H0):
There is no difference in Smriti (Working memory) of shift workers following different sleep
patterns to the normal shift workers (day shift workers) following normal sleep patterns.

ALTERNATE HYPOTHESIS (H1):
There is difference in Smriti (Working memory) of shift workers following different sleep
patterns to the normal shift workers (day shift workers) following normal sleep patterns.

INTRODUCTION:

यदा तु मनसि क्लान्ते कमाात्मानः क्लमान्विताः |
सिषयेभ्यो सनितान्ते तदा स्वसिसत मानिः||1 ( च. िू. २१/३५)

Nidra is one of the three Upstambha of life. It is as important as that of Ahara and
Brahmcharya. It is said that when Mana gets exhausted due to excessive work and Indriyas
also gets rid of their work due to tiredness, then one sleeps.

अकालेऽसतप्रिङ्गाच्च न च सनद्रा सनषेसिता |
िुखायुषी िराकु याात् कालरासिररिािरा ||2 (च. िू. २१/३७)

Also it is said that Nidra taken out of time or in excessive amount or not taken properly is as
harmful as Kalratri and takes happiness away.
In Ayurveda text six types of Nidra are given in which ratriswabhava nidra is the nidra taken
at night and it is also consider as physiological .other five types are due to some pathology.3

रािौ जागरणं रूक्षं ……….. I4 (च. िू. २१/५०)

When this Ratriswabhav Nidra is hampered due to any reason and person wakes up throughout
night it causes vata dosh vruddhi. When vata dosha vruddhi occurs it affects Smriti.

स्मृसतबुन्विप्रमोहश्च………….II5 (च .िू .२१/४८)

Also Divaswpn (day sleep) causes Smritibuddhimohasch.
In Sushrut Samhita lakshan of Nidra taken in Samyaka kala are mentioned as

पुष्टि वर्ण बलोत्साहमष्टि दीप्तिमतंष्टिताम् ।
करोष्टत धातु साम्यं च ष्टििा काले ष्टिषेष्टवता ।।6 (िु. सच
. २४ /८८ )

Nidra taken at proper time causes nutrition of body, increment of complexion, strength and
joy. It increases agni, and causes proper balance of all the dhatus.
Smriti Vibhramsha is the state in which the memory is altered from its normalcy; this means
either reduced memory or selective memory or total loss of memory. In various classics,
scattered knowledge of Smritihrasa can be concluded as: Mana when hindered by Vata
pradhana Smriti Vibhramsha tridosha prakopa, leads to Rajo and Tamo Guna Vriddhi and
causing Avarana of Manovaha Srotasa (occlusion in channels of psychic activities) thereby
finally leading to Dhi, Dhriti and Smriti Vibhramsa7.
In modern science, Sleep quality is the measurement of how well you’re sleeping—in other
words, whether your sleep is restful and restorative. Four items are generally assessed to
measure sleep quality:8
Sleep latency: This is a measurement of how long it takes you to fall asleep. Drifting off
within 30 minutes or less after the time you go to bed suggests that the quality of your sleep
is good.
Sleep waking: This measures how often you wake up during the night. Frequent wakefulness
at night can disrupt your sleep cycle and reduce your sleep quality. Waking up once or not at
all suggests that your sleep quality is good.
Wakefulness: This measurement refers to how many minutes you spend awake during the
night after you first go to sleep. People with good sleep quality have 20 minutes or less of
wakefulness during the night.
Sleep efficiency: The amount of time you spend actually sleeping while in bed is known as
sleep efficiency. This measurement should ideally be 85 percent or more for optimal health
benefits.
Working memory9 is a cognitive system with a limited capacity that can hold information
temporarily. It is important for reasoning and the guidance of decision-making and behaviour. 
Working memory is often used synonymously with short-term memory, but some
theorists consider the two forms of memory distinct, assuming that working memory allows
for the manipulation of stored information, whereas short-term memory only refers to the
short-term storage of information. Working memory is a theoretical concept central
to cognitive psychology, neuropsychology, and neuroscience.

NEED OF THE STUDY:

• In the description of Nidra, Ratriswabhav Nidra is naturally occurring as a
physiological process, others are due to some pathology
• As per Ayurveda Ratrijagaran causes Vata dosha vriddhi and Rukshta in the body.
Also, it is said that when Vata vriddhi occurs it affects the Smriti of the individual.
• “Currently more than 55 million people have dementia worldwide, over 60% of whom
live in low-and middle-income countries. Every year, there are nearly 10 million new
cases”.(WHO, March 2023)
• In Ayurveda Nidra and Smriti are considered to be closely associated but the evidence
for the same is less. This study is an approach to find out the association of Nidra and
Smriti, to fill the gap between concepts.
• It is needed to generate the evidence for evaluation of the association of Prakriti with
Nidra and Smriti which has been mentioned in classical Ayurvedic literature.

LITERATURE REVIEW:

CLASSICAL REVIEW:
1. In Charaka Samhita sutra sthan ekadashadyaya Acharya Charaka mentioned Nidra in
Trayaupstambh and it should be practice with caution. Also Nidra is one of the
Adharneeya Vega. Detailed description about Nidra is given in Charak sutra ekvinshati
adyaya asthauninditiya adhyaya.
2. In Sushrut Samhita, Nidra is mentioned as one of the five swabhavika roga.In Sushrut
Chikitsa 24 properties of kala nidra sevan are given.
3. Acharya Vagbhatt also refer Nidra as upstambh and adharneeya Vega.
In short all the acharyas mentioned nidra as an important factor for life and its contribution in health. Also Ratrijagaran and Divaswapa are prohibited.
Smriti Vibhramsha is the state in which the memory is altered from its normalcy; this
means either reduced memory or selective memory or total loss of memory. In various
classics, scattered knowledge of Smritihrasa can be concluded as: Mana when hindered
by Vata pradhana Smriti Vibhramsha tridosha prakopa, leads to Rajo and Tamo Guna
Vriddhi and causing Avarana of Manovaha Srotasa (occlusion in channels of psychic
activities) thereby finally leading to Dhi, Dhriti and Smriti Vibhramsa.

CONTEMPORARY REVIEW:
Sleep is a physiological process by which bodily functions are periodically rested. During
sleep, consciousness and power of will are partially or completely suspended and bodily
activity generally is greatly reduced. Sleep differs from alert wakefulness by loss of critical
reactivity to events in the external environment, therefore, subject can be aroused by sensory
stimulation.
Sleep requirement: 1. Newborn: 18 to 20 hrs
2. Growing children: 12 to 14 hrs
3. Adults: 7 to 9 hrs
4. Old persons: 5 to 7 hrs
Working memory (WM) is a cognitive construct that refers to the process of short-term
storage and management of information. Although it is often used as a synonym of shortterm
memory (STM), WM is frequently used to convey an additional emphasis on the
active manipulation of buffered information. In contrast, STM refers to information
storage without any type of manipulation and is, in fact, a key underlying process of
WM. It has often been connected or related to intelligence, information processing,
executive function, comprehension, problem-solving, and learning, in people ranging
from infancy to old age.

PREVIOUS WORK DONE:

S.NO.

TITLE              OF

ARTICLE

JOURNA

L

YEAR OF

PUBLICA

TION

AUTHOR

SUMMARY

1.

Ratrijagarana night wakefulness and its impact on Manasika Bhava mental characteristics among industrial workers: A descriptive crosssectional study10

 

JAIMS 

2021

 Elgeena

Varghese et al

A substantial change in Mana (non-distracted mind),

Chinta(anxiety/worry),

Dhairyam (courage), Harsha (joy), Veeryam (energy), Shraddha (desire), Medha

(intelligence),Avasthaana

(stability of mind), Vignyaana

(knowledge),                      Sanjna

(recognition), and      Smriti (memory).

2.

RATRIJA

GARANA

(SLEEP

DEPRIVA

TION): A

MENACE

FOR

LIFESTY

LE

DISORDE

RS—A

REVIEW

11

IAMJ

2023

Thanusree        N

Nair

To prevent this sort of disease due to sleep deprivation, as per Acharya Charaka, those who are awakened during the night hours due to their work schedule the next day before the intake of food should sleep half of the awakened hours.


3.

Disturbance of the Circadian System in Shift Work and

Its Health

Impact12

 

  

 

PMC

 30      dec,

2021

Diane              B.

Boivin, Philippe Boudreau, and Anastasi

Kosmadopoulos

Shift work leads to acute and chronic disturbances of sleep and alertness and an increased risk of fatigue-related incidents and accidents 

4.

              Lack      of

Sleep May

Increase

Dementia

Risk13

NIH

14may

,2021

-

Analysis of the data showed that people in their 50s and 60s who got 6 hours of sleep or less were at increased risk of developing dementia later. Further research is needed to confirm this connection and understand the underlying reasons.   

5.

The effects of three consecutive 12-hour shifts on cognition, sleepiness, and domains of nursing performance in day and night shift nurses: A quasiexperimental

study14

 

 

 November

2021

Lois James , Nat haniel ElkinsBrown , Marian Wilson , Stephe n

M. James , Eliza beth Dotson , C harles

D. Edwards , La ura Winterstee n-

Arleth , Kevin St evens , Patricia Butterfield 

 

Nurses maintained their levels of performance for all domains after three consecutive shifts. Individual differences in predicted cognitive effectiveness could account for variation in performance by shift type for Communication skills but for no other domain of performance.  


OBJECTIVES OF THE RESEARCH:

PRIMARY OBJECTIVE:
1. To assess the impact of Nidra (Sleep quality) on Smriti (Working memory) of
individuals working in different shifts.

SECONDARY OBJECTIVES:
1. To assess the association of Deha Prakriti with Nidra (Sleep quality) and Smriti
(working memory) of individuals working in different shifts.

MATERIALS AND METHODS:

Study Setting:- Delhi NCR
Study type:- Retrospective, Analytical cross sectional study
Population:- Shift workers (Day & Day-Night shift)
Grouping:- Two arm study
Group A: Day shift workers (working at the time for a minimum of 8 hours from atleast
past six months)
Group B: Day-Night shift workers (working at alternate day-night shift minimum 8 hours
for 15-30 days/month from atleast past six months)
Sample size – 100 in each group

SAMPLE SIZE CALCULATION:
Since we wish to know if work related shifts causes loss in memory scale, so we will
come to compare day shift workers and day-night shift workers for their memory status.
Here day shift workers means adults regularly working in day time & others means
day-night shift workers. Thus day-night shift workers may be treated as inference
group. Assuming that 20% point’s reduction may results due to shift workers sleep
patterns.

The calculated p value is 93 per group, assuming alpha 0.5, power 80% two sided test
assuming 10% dropout 102

Inclusion Criteria:
• Apparently healthy individuals of the age group 25-45 years irrespective of gender,
caste, and religion.
Participants should be Literate.
• Individuals, willing to participate.
• Group A: Day shift workers (working in day time for a minimum of 8 hours for at least
the past six months)
• Group B: Day-Night shift workers (working at alternate day-night shift minimum 8
hours for 15-30 days/month from at least the past six months

Exclusion Criteria:
Individuals having a history of any head injury, head surgery
• Individuals having a history of any major medical illness (HTN, DM, Parkinson’s
disease, Alzheimer’s disease, etc.)
• Individuals consuming any kind of medications, narcotics, etc. to induce sleep
• Individuals taking any medication to enhance memory.
• Individuals having drug and addiction (smoking) history.
• Pregnant and lactating mothers.

ASSESSMENT CRITERIA:
• Swasthya assessment scale (CSIR-IGIB/CCRAS) (Annexure 1)
• Prakriti pariksha using CCRAS Prakriti assessment Scale.
• Sleep quality assessment tool (Pittsburg Sleep quality Index).(Annexure2)
• PGI memory scale.(Annexure3)
• Lab investigation (for screening purpose) - CBC, Blood sugar, LFT, KFT, Thyroid
profile, Lipid profile.
• Melatonin hormone test (in selected participants, if feasible )

METHOD OF DATA COLLECTION:
• The data of the selected participants (those who comply with the inclusion criteria and
willing to take part in the study) will be collected.
• The selected participants shall undergo the series of events which include informed
consent about the study, their demographic details, a detailed history will be taken as
per the requirements of the study.

METHODOLOGY:
All involved procedures will be explained to the participants and written consent will be
taken.
A. Swasthya assessment & Lab investigations:
• Participant’s health will be assessed with the help of Swasthya assessment scale.
• Questions given in the scale will be asked and responses will be noted on the sheet.
• Assessment will be done on the basis of scoring & lab investigations. Apparently
healthy individuals will be screened and enrolled after fulfilling the inclusion criteria
for the next step of study.
B. Prakriti Parikshan
• Enrolled participants will be proceeded with assessment of Prakriti with the help of
CCRAS prakriti assessment scale.
C. Sleep quality assessment:
• Sleep quality will be checked with the help of PSQI
• Responses will be noted on the sheet
• Scoring will be done and participants will proceed for the next steps.
D. Memory assessment Test:
• Participants will be explained the SOP (Annexure 1) of the PGI memory assessment
scale before starting the test.
• Test will be done and responses will be noted.
• Interpretations will be done and conclusion will be noted.

END POINTS:
Primary end point – An association between Nidra and Smriti working memory will be
obtained.
Secondary end point –
1. Corelation between nidra and deha prakriti will be established.
2. Variation in working memory scale in relation with deha prakriti will be assessed


FLOW CHART OF OBSERVATIONAL STUDY
Individuals will be screened and participants will be
enrolled after taking written consent of the participants.
Swasthya assessment will be done using IGIB/CCRAS
swasthya assessment scale & lab investigation will be done.
Apparently healthy participants will get divided in group A and
group B as per the inclusion criteria.
Prakriti assessment will be done by using CCRAS
Prakriti assessment scale.
Sleep quality of the participants of both the groups will
be assessed by using PSQI
Memory assessment of both the groups will be done
using PGI memory scale
Data collected from every tool will be statistically
analyzed, discussion will be done, conclusion will be
drawn

STATISTICAL METHOD FOR ANALYSIS:
❑ The generated data will be presented in the form of Frequency distribution, Bar
diagrams wherever applicable and Chi-Square test will be used to compare between
groups.
❑ The data generated in the observational study will be analyzed to compare proportion
memory loss by using Z-TEST and other suitable tests will be used as per need.
❑ SPSS (Statistical Package for the Social Sciences) version 26 of programme will be
used.
❑ Data will be stored in password protected computer and at the end of the study all the
data will be handed over to the department.

ACCESS TO DATA AND CONFIDENTIALITY
Data confidentiality will be maintained and Primary data will be preserved in the concerned
Department for a period of 5 years.

ETHICS COMMITTEE CLEARANCE
• The study will be started only after getting clearance from Institutional Ethics Committee,
AIIA, New Delhi.
• The present study will be carried out after taking the written consent from the Study
Participants.
• The CTRI Registration will be done.

EXPECTED OUTCOME
- Decrease in working memory score will be obtained in disturbed sleep pattern
individuals.

FINANCIAL SUPPORT
PGI memory scale- 5,000
Melatonin kit- 40,000
Lab investigations- 180,000 (waived off by institute for research purpose)
Transport expenses- 30,000
Miscellaneous – 2,000
TOTAL- 257,000

This study will be completed within the prescribed financial limit for the work. However, if
more finance is required, the request will be made for due permission and approval of extra
budget to the concerned authority AIIA, in due course of research work
 
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