| 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
|
|
|
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
|
|
|
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 |