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CTRI Number  CTRI/2025/09/095448 [Registered on: 29/09/2025] Trial Registered Prospectively
Last Modified On: 26/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Effect of good sleep practices on neurodiverse children 
Scientific Title of Study   Effect of sleep hygiene education on sleep patterns and behavior in neurodiverse children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raj Amrit Ranjan 
Designation  Undergraduate  
Affiliation  Kasturba Medical College Mangalore 
Address  Student, Department of Paediatrics, Room number 4, RAPCC, Kasturba Medical College Mangalore,Lighthouse hill road ,Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9035870206  
Fax    
Email  raj.ranjan@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Raj Amrit Ranjan 
Designation  Undergraduate  
Affiliation  Kasturba Medical College Mangalore 
Address  Student, Department of Paediatrics, Room number 4, RAPCC, Kasturba Medical College Mangalore,Lighthouse hill road ,Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9035870206  
Fax    
Email  raj.ranjan@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Raj Amrit Ranjan 
Designation  Undergraduate  
Affiliation  Kasturba Medical College Mangalore 
Address  Student, Department of Paediatrics, Room number 4, RAPCC, Kasturba Medical College Mangalore,Lighthouse hill road ,Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9035870206  
Fax    
Email  raj.ranjan@learner.manipal.edu  
 
Source of Monetary or Material Support  
District Early intervention centre, Government wenlock hospital, Mangalore,575001 
Kasturba Medical College Mangalore,Lighthouse hill road ,Mangalore,575001 
 
Primary Sponsor  
Name  Kasturba Medical College Mangalore  
Address  Lighthouse hill road, Mangalore,575001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Raj Amrit Ranjan  District Early Intervention Centre   Government Wenlock Hospital, Mangalore, 575001
Dakshina Kannada
KARNATAKA 
9035870206

raj.ranjan@learner.manipal.edu 
Raj Amrit Ranjan  KMC Hospital Attavar  KMC Hospital Attavar, Attavar Mangalore , 5750001
Dakshina Kannada
KARNATAKA 
9035870206

raj.ranjan@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Medical College Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F79||Unspecified intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  standard treatment  Lifestyle modification suggested during regular treatment, which includes maintaining good sleep  
Intervention  Teaching module for sleep hygiene   Concise teaching module, which will be used by the investigator to teach the caregiver about sleep hygiene practices. The module is divided in four segments which focus on sleep positioning and bedding, sleeping environment, sleeping practices and sleep scheduling. Each of these sections have their set of information that will be given to the caregiver. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All the participants are caregivers of individuals between the ages of 4 to 12 who are fluent in either Hindi , English or Kannada and willing give consent. And are on the usual course of treatment. 
 
ExclusionCriteria 
Details  Those who do not give consent, incomplete entries, on sleep modifying drugs or do not meet the language criteria. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a.proportion of children with sleep abnormalities.
b.Changes in sleep pattern and behaviour following sleep intervention.
c.caregiver satisfaction post intervention
 
a.proportion of children with sleep abnormalities - baseline
b.Changes in sleep pattern and behaviour following sleep intervention. - after two months
c.caregiver satisfaction post intervention - after two months
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   Phase 2 
Date of First Enrollment (India)   15/10/2025 
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="3"
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  

The study will commence after taking permission from the institutional ethics committee and superintendent of the respective hospitals. Sample recruitment will start after CTRI registration The caregivers of the children visiting hospitals will be approached. written informed consent will be taken from all study participants   who will be selected based on inclusion and exclusion criteria .They will be interviewed about sleep habits of their children, and the data collection will be done by a child sleep habits, questionnaire (CSHQ ) ,a structured questionnaire which will be used pre-interventional in Google form-format by the investigator during an interview conducted in the language in which the caregivers are comfortable. Following this the the children with sleep abnormalities will be recruited into the intervention where caregivers will be taught about sleep hygiene methods via a module developed by the investigator in the language, they are comfortable in a one-on-one session, with a standard time of 20 minute each. Participants will be provided opportunity to clear doubts. They will be asked to follow these methods for the next two months. Text messages through WhatsApp or SMS will be sent thrice a week and phone call will be made once a week to ensure compliance. After this, 2 months post-intervention the caregivers will be interviewed by the investigator about the changes in child, sleep pattern and behaviour following the intervention using CSHQ and a caregiver satisfaction scale (made by the investigator) . Once the questionnaire is complete, data will be checked for completeness, inconsistencies, and missing values, with incomplete responses excluded from the final analysis. Descriptive statistics will be used to analyse baseline characteristics of participants, including demographics and reported sleep issues, through frequencies, percentages, mean, and standard deviation. Pre- and post-intervention scores will be compared using paired t-test or a Wilcoxon signed-rank test .Effect size calculation will be performed using Cohen’s d or rank-biserial correlation to measure the intervention’s impact on sleep improvement. Significance level and interpretation will be based on a p-value of <0.05.


 
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