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CTRI Number  CTRI/2024/01/061768 [Registered on: 23/01/2024] Trial Registered Prospectively
Last Modified On: 09/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational Intervention]  
Study Design  Other 
Public Title of Study   Effectiveness of Sleep hygiene education on sleep quality and daytime sleepiness among elderly population in Imphal, Manipur. 
Scientific Title of Study   Effectiveness of Sleep hygiene education on sleep quality and daytime sleepiness among elderly population in Imphal District, Manipur: A non-randomised controlled trial 
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 Ranchandra Nandeibam 
Designation  Post Graduate trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Community Medicine, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795002
India 
Phone  6009818809  
Fax    
Email  nranchandra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shantibala Konjengbam 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Community Medicine, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795002
India 
Phone  9436027274  
Fax    
Email  shantibaladr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ranchandra Nandeibam 
Designation  Post Graduate trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Community Medicine, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795002
India 
Phone  6009818809  
Fax    
Email  nranchandra@gmail.com  
 
Source of Monetary or Material Support  
Department of Community Medicine ,Regional institute of Medical Sciences, Imphal, Manipur 
 
Primary Sponsor  
Name  Dr Ranchandra Nandeibam 
Address  Community Medicine Department, RIMS, Imphal 
Type of Sponsor  Other [Self] 
 
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 Ranchandra Nandeibam  Regional institute of medical sciences  Seminar hall, department of Community Medicine
Imphal East
MANIPUR 		 6009818809

nranchandra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research ethics board, Regional Institute of Medical Sciences(RIMS), Imphal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Having poor sleep 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  No intervention will be given 
Intervention  Sleep hygiene education  A single session for a group of 5-7 participants which includes: 1. Sleep Hygiene education for around 1 hour, followed by 2.Discussion on sleep hygiene with Do’s and Don’ts for good sleep hygiene pamphlet for around 1 hour  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Aged 60 years and above, residing in the district for at least one year, with Pittsburg sleep quality index of more than 5 , having Mini Cog test more than 3, and those who can read and understand Manipuri(Bengali script) and English 
 
ExclusionCriteria 
Details  Those who are receiving sleep medication and any anti-psychotic medicine, clinically diagnosed with any psychiatric illness and those who are bedridden 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sleep quality and day time sleepiness  1 month after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Sleep hygiene behavior  1 month after intervention 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   25/01/2024 
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="6"
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   Sleep is an essential part of human functioning and a rhythm of life that allows our body and mind to recharge, restoring the body’s energy and leaving us refreshed. No matter what the age is, sleeping well is essential for physical health and emotional wellbeing. Sleep disorders or poor sleep is a complex health problem prevalent among the general population regardless of age. Still, the prevalence of poor sleep increases with age and considering the impact sleep disturbance can have on health, it is important to pay special attention to sleep quality among the elderly. To achieve greater sleep efficiency combination therapy is recommended such as sleep hygiene education, psychological therapies, and pharmacological interventions. Poor sleep hygiene is considered to be one of the important factors contributing to sleep disorders. Sleep hygiene is the concept used to relate healthy sleeping practices and is one of the non-pharmacological interventions. Sleep Hygiene Education is intended to provide knowledge on lifestyle (diet, exercise, drug use) and environmental variables (light, noise, temperature) that will encourage better sleep. Sleep hygiene also includes suggestions to facilitate overall sleep, such as providing enough time to relax before bedtime and information about the advantages of regular sleep schedules. Using health-related educational programs will not only improve the quality of sleep, quality of life and overall health but will further reduce healthcare costs and health-related burden. An educational intervention study to evaluate the effectiveness of sleeping hygiene education on sleep quality and daytime sleepiness of elderly people in Imphal, Manipur. 
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