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CTRI Number  CTRI/2024/07/069923 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Sleeping in dark or light]  
Study Design  Single Arm Study 
Public Title of Study   Effect of sleeping in dark on cognition in undergraduate students 
Scientific Title of Study   Study of effect of sleeping in dark and light on cognition in undergraduate students 
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 Allampalli Sirisha 
Designation  Assistant Professor 
Affiliation  S V Medical College 
Address  Dept. of Physiology, SV Medical College, tirupati, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9489332439  
Fax    
Email  siribangaram2020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Setty Sneha 
Designation  BSc (Neurophysiology) Student 
Affiliation  S V Medical College 
Address  Dept. of Physiology, SV Medical College, Tirupati, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  8008014154  
Fax    
Email  snehasetty0118@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Allampalli Sirisha 
Designation  Assistant Professor 
Affiliation  S V Medical College 
Address  Dept. of Physiology, SV Medical College, tirupati, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9489332439  
Fax    
Email  siribangaram2020@gmail.com  
 
Source of Monetary or Material Support  
SV Medical College under DR. YSR University of Health Sciences, Tirupati, Andhra Pradesh, India - 517507 
 
Primary Sponsor  
Name  SV Medical College 
Address  SV Medical College under DR YSR University of Health Science, Tirupati, Andhra Pradesh, India - 517507 
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 Allampalli Sirisha  SV Medical College  Lab No:2, Clinical Lab, Dept.of Physiology
Chittoor
ANDHRA PRADESH 
9489332439

siribangaram2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SV Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sleep and cognition in healthy volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Light in the room  Subjcets will be asked to sleep with light on for one month 
Intervention  Subjects will be asked to change their room settings to dark  Induction of darkness during sleep for one month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  Apparently healthy undergraduate students who are willing to participate in the study  
 
ExclusionCriteria 
Details  Students who are having insomnia, who are practicing meditation, who are on any medication which alters sleep physiology, with any other illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Quality of sleep   30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Cognitive performance  30 days 
 
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)   15/07/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

A written and informed consent was obtained from the participants prior to the study. After taking the baseline data of name, age and gender, height and weight of the participants along with basal blood pressure werebe recorded. Then, the participants were asked to answer two questionnaires i.e., Sleep Quality Scale (SQS) and Pittsburgh Sleep Quality Index (PSQI), based on their subjective sleep experience. After completing the sleep questionnaires, a battery of neurocognitive tests were performed by the participants namely, letter cancellation test, forward and backward digit span recollection test, Montreal cognitive assessment test (all the questionnaires are attached).

            After the baseline recordings, all the participants were divided broadly into 2 categories with their present preferences of sleeping in dark or light. From this broad category participants were randomly divided into 2 groups each (Fig-1) with one group choosing to have change in sleeping setting to light or dark and one group did not change in any sleep settings. According to their division of group, the participants were asked to change their settings of the sleeping room in terms of light/darkness for a period of one month. After a month of exposure to darkness or light, all the parameters recorded at the baseline were recorded once again and the questionnaire answered at the baseline were answered by the participants again and the data before and after the change in sleep in darkness or light was compared by using Student’s paired t test. Also the data in between the groups after the change of room darkness or light was analyzed by using One Way ANOVA

 
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