FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/02/040643 [Registered on: 25/02/2022] Trial Registered Prospectively
Last Modified On: 06/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Find out the common sleep problems in Autism children  
Scientific Title of Study   A cross sectional study on prevalence of sleep disturbances in Autism spectrum disorder in children reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D Manikandan 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  7373464836  
Fax  044-22381314  
Email  manikavi247@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Meenakshi Sundaram MDS PhD 
Designation  Professor & HoD 
Affiliation  National Institute of Siddha 
Address  Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444214582  
Fax  044-22381314  
Email  mmssiddha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Meenakshi Sundaram MDS PhD 
Designation  Professor & HoD 
Affiliation  National Institute of Siddha 
Address  Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444214582  
Fax  044-22381314  
Email  mmssiddha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 
Type of Sponsor  Research institution and hospital 
 
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 D Manikandan  Ayothidoss Pandithar Hospital  Room no 9,Kuzhanthai Maruthuvam OPD,Department of Kuzhanthai Maruthuvam,Ayothidoss Pandithar Hospital,National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU 		 7373464836
044-22381314
manikavi247@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children with Autism Spectrum Disorder, along with informed consent from their parents. 
 
ExclusionCriteria 
Details  Children with other additional developmental disorders. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Will estimate the prevalence of sleep disturbances in autism children.  1 month - Screening
1 month - Patient enrolment
1 month - outcome assessment 
 
Secondary Outcome  
Outcome  TimePoints 
To provide awareness about children sleep hygiene away parents  1 month - Screening
1 month - Patient enrolment
1 month - outcome assessment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/02/2022 
Date of Study Completion (India) 02/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
BACKGROUND:
Autism Spectrum Disorder (ASD), a neurodevelopmental disorder with a prevalence of 1 in
68 children, commonly presents with comorbid conditions which include sleep disorders. Sleep
disorders reported in ASD include, among others, increased bedtime resistance, insomnia,
parasomnia, sleep disordered breathing, morning rise problems, and daytime sleepiness.
Polysomnography studies show that children with ASD have altered sleep architecture including
shorter total sleep time and longer sleep latency than typically developing peers. Sleep related
problems have been shown to affect overall autism scores, social skills deficits, stereotypic
behavior, and cognitive performance. Additionally, problematic sleep in children with ASD has
been associated with higher levels of parental stress. The prevalence of Autism Spectrum Disorder
(ASD) is on the rise. Apart from the core behavioral issues of impaired social interaction, and
restricted and / or repeated behavioral phenotype, comorbidities like sleep problems are
increasingly getting recognized as important determinants of management and overall quality of
life. Children’s Sleep Habit Questionnaire (CSHQ) is a widely used measure in ASD.
AIM AND OBJECTIVE:
To estimate the prevalence of sleep disturbances in autism spectrum disorder in children by
usingchildren’s sleep habit questionnaire (CSHQ).
STUDY DESIGN:
A hospital based Cross sectional study on using purposive sampling technique which will
be carried out for 3 months at Ayothidoss Pandithar hospital, National Institute of Siddha. A total
of 30 Parents/Guardians having children within the age limit of 3-12 years willing to participate in
this study, by signing the consent form and assent will be enrolled in the study.
RESULTS:
In this study, overall, 30 ASD children with their parents were seen over this period.
Out of 30 children with ASD, 15 (50%) ASD children had high score (≥41) of CSHQ, which was
considered indicative of presence of sleep disturbances and 15 (50%) children had low score (<41)
of CSHQ and don’t have sleep problems. Thus, in the entire population of children with ASD, the
total prevalence of sleep disturbances was 15 (n/N = 15/30) with 50%.
CONCLUSION:
The prevalence of sleep disturbances in ASD is significantly higher in children in this
study. In the clinic, sleep assessment should be included in the routine of ASD visits, and during
intervention, sleep hygiene education is as important as the treatment of biological factors.
KEY WORDS: Autism Spectrum Disorder, Sleep problems, Children’s Sleep Habits
Questionnaire.
 
Close