| 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
|
|
|
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
|
|
|
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.
|