Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-01-18
Brief Title:
Development and Validation of a Comprehensive Module for Management of Sleep Disorders in ASD Children
Sponsor:
All India Institute of Medical Sciences New Delhi
Organization:
All India Institute of Medical Sciences New Delhi
Study Overview
Official Title:
Development and Validation of a Comprehensive Module for Management of Sleep Disorders in Children With Autism Spectrum Disorder Aged 4-10 Years a Pre and Post Intervention Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sleep disorder in autism children is common and it affects the physical behavior and mental health There is lack of comprehensive management programmodule to treat the sleep disorders in children with ASD Limited studies evaluating the utility of actigraphy to diagnose sleep disorders in ASD and its validation with PSG are present Rationale of this study is to develop the comprehensive module and validate it for children with autism spectrum disorders so as to improve the behavioral outcomes as well This study also helps to utilize actigraphy as a modality to diagnose sleep disorders in children with autism spectrum disorder as performing PSG in these children is cumbersome and difficult as ASD children tend to have sensory abnormalities
Detailed Description:
Development of module for management of sleep disorders in children with ASD will be done by Delphi method
Proposed components of Module include
Behavioral intervention
1 Modifying stimulus by change in location of sleep onset using bedtime stories
2 Giving schedules to activities which interfere with sleep before bedtime itself so they dont disturb the sleep onset now
3 Using a bedtime pass which allows children to make a predetermined number of requests for parental attention while in bed
4 Giving sleep items like cuddle toys to replace the parental presence
5 Delaying the bedtime so the child feels urge to sleep and slowly decreasing that time
6 Sleep hygiene by providing suitable environment for child to sleep providing proper bedtime routine sleep wake schedules
7 Providing rewards for children who followed the good bedtime routine as positive reinforcement
Pharmacological intervention
1 For children diagnosed with sleep disorders due to underlying ENT pulmonary conditions to treat them accordingly as per standard protocol available
2 Usage of melatonin if required for sleep onset difficulty
An 80 agreement over an intervention will be included in the module The module will be developed within 3 months and ethical approval will be taken for application of this intervention
Children aged 4 to 10 years attending Pediatric autism clinic and diagnosed with ASD using DSM V criteria who are on follow up with behavioral therapy at least for 6 months will be included in the study On routine comprehensive evaluation those children with refractory epilepsy and ASD children with tuberous sclerosis fragile X syndrome and Down syndrome and metabolic disorders will be excluded
The child will undergo screening for identification of sleep disorders initially
They will be called around 11 am on the day of assessment from 12 noon they will be made to wear the actigraphy watch on the non-dominant wrist
They will undergo evaluation on CSHQ half and hour before the stipulated bedtime PSG electrodes will be attached till lying on bed at the night time the actigraphy parameters will be recorded as daytime data once on the bed at night the data will be recorded as nocturnal actigraphy data The PSG electrodes will be removed next morning immediately after the child gets up from sleep Actigraphy watch will be removed at 12 noon the next day
The CSHQ will be administered by the principal investigator in Hindi or English
Parents will be asked to answer the questions based on the sleep habits of the child based on the past week In case the last week was unusual for a specific reason the questions were answered with respect to the most recent typical week Appointment for overnight PSG will be given as per the convenience of the family
Parents will be advised to continue the childs usual pattern of sleep prior to the test
For children who are on pharmacological therapy for seizures and behavioral issues drugs will be continued so as to not interfere with the childs treatment and conform to ethics
The parents will be told to bring the child on the day of the study with his or her night clothes along with pillows bedsheets and any other sleep association objects that the child wanted
The parents will be shown the laboratory once before the actual testing This will help them in replicating the childs routine sleeping pattern as far as possible in the PSG lab on the night of testing
Standard overnight multichannel PSG evaluation will be performed with Philips Respironics Alice 6 LDxS PSG system with Axis 5521 PTZ high-resolution camera
PSG scoring and reporting will be done according to American Academy of Sleep Medicine Manual version 25 and International Classification of Sleep Disorders -3 manual
The PSG record will be analyzed by Pediatric neurology faculty who are blinded to clinical status and Actigraphy scoring and reporting will be done
Complete evaluation of behavior ATEC CBCL CARS-2 sensory profile DP-3 and ABC will be done for all children undergoing screening polysomnography actigraphy on the same day
CARS is done to estimate the severity of autism It is different for high functioning children IQ 80 age 6 years with fluent speech with scores of 15-275 being minimal 28-335 mild to moderate and more than 34 is severe For other children age 6 years without fluent speech score of 15-295 15-275age for 13IQ80 is minimal 30-365 age 6 years without fluent speech 28-345age for 13IQ80 is mild to moderate and age 6 years without fluent speech score of 37 and higher score of 35 and higher age for 13IQ80 shows severe symptoms of Autism Spectrum Disorder The CARS is a 15-item scale used to grade the severity of autism in 14 behavioral domains
CBCL is used for determining the behavioral comorbidities The CBCL assesses behavior in 11 domains and there are two sets of questionnaires one for 15 to 5 years of age and another for 5 to 18 years of age which is separate for boys and girls
Development Profile 3 DP3 is used to estimate the development or intelligent quotient The DP3 assesses DQIQ in 5 domains Physical behavior Adaptive Behavior Cognition Social Emotional and Communication by parental reporting as well as direct observation
The Autism Treatment Evaluation Checklist ATEC was designed to assist parents physicians and researchers to evaluate virtually any treatment for autism It includes scoring in Speech Language Communication sociability sensory and cognitive awareness healthphysicalbehavior
The Autism Behavior Checklist ABC was designed to offer a method to more objectively identify autism in children The scale utilizes an observers rating of the childs behavior to quantify behaviors typically associated with Autism The ABC was developed as a clinical measure to screen for autism in individuals 3-35 years of age The scale was developed in 1980 and has not undergone revision since then The ABC consists of 57 items and 5 scales 1 Sensory 2 Relating 3 Body and Object use 4 Language and 5 Social and Self-help
If the child is found to have sleep disorder according to ICSD -3 criteria then they will be enrolled in the study after informed consent to undergo intervention
They will be given module-based intervention according to the disorder child is found to have
They will be followed up telephonically every 2 weeks and in OPDClinic every 4 weeks to ensure compliance with intervention
After 6 months of intervention CSHQ PSG and actigraphy evaluation of behavior ATEC CBCL CARS-2 sensory profile DP-3 and ABC will be repeated in the same method used before giving intervention
Pre and post CSHQ scores actigraphy and polysomnography behavioral scores will be compared and correlation between actigraphy and polysomnography will be measured
Proposed components of Module include
Behavioral intervention
1 Modifying stimulus by change in location of sleep onset using bedtime stories
2 Giving schedules to activities which interfere with sleep before bedtime itself so they dont disturb the sleep onset now
3 Using a bedtime pass which allows children to make a predetermined number of requests for parental attention while in bed
4 Giving sleep items like cuddle toys to replace the parental presence
5 Delaying the bedtime so the child feels urge to sleep and slowly decreasing that time
6 Sleep hygiene by providing suitable environment for child to sleep providing proper bedtime routine sleep wake schedules
7 Providing rewards for children who followed the good bedtime routine as positive reinforcement
Pharmacological intervention
1 For children diagnosed with sleep disorders due to underlying ENT pulmonary conditions to treat them accordingly as per standard protocol available
2 Usage of melatonin if required for sleep onset difficulty
An 80 agreement over an intervention will be included in the module The module will be developed within 3 months and ethical approval will be taken for application of this intervention
Children aged 4 to 10 years attending Pediatric autism clinic and diagnosed with ASD using DSM V criteria who are on follow up with behavioral therapy at least for 6 months will be included in the study On routine comprehensive evaluation those children with refractory epilepsy and ASD children with tuberous sclerosis fragile X syndrome and Down syndrome and metabolic disorders will be excluded
The child will undergo screening for identification of sleep disorders initially
They will be called around 11 am on the day of assessment from 12 noon they will be made to wear the actigraphy watch on the non-dominant wrist
They will undergo evaluation on CSHQ half and hour before the stipulated bedtime PSG electrodes will be attached till lying on bed at the night time the actigraphy parameters will be recorded as daytime data once on the bed at night the data will be recorded as nocturnal actigraphy data The PSG electrodes will be removed next morning immediately after the child gets up from sleep Actigraphy watch will be removed at 12 noon the next day
The CSHQ will be administered by the principal investigator in Hindi or English
Parents will be asked to answer the questions based on the sleep habits of the child based on the past week In case the last week was unusual for a specific reason the questions were answered with respect to the most recent typical week Appointment for overnight PSG will be given as per the convenience of the family
Parents will be advised to continue the childs usual pattern of sleep prior to the test
For children who are on pharmacological therapy for seizures and behavioral issues drugs will be continued so as to not interfere with the childs treatment and conform to ethics
The parents will be told to bring the child on the day of the study with his or her night clothes along with pillows bedsheets and any other sleep association objects that the child wanted
The parents will be shown the laboratory once before the actual testing This will help them in replicating the childs routine sleeping pattern as far as possible in the PSG lab on the night of testing
Standard overnight multichannel PSG evaluation will be performed with Philips Respironics Alice 6 LDxS PSG system with Axis 5521 PTZ high-resolution camera
PSG scoring and reporting will be done according to American Academy of Sleep Medicine Manual version 25 and International Classification of Sleep Disorders -3 manual
The PSG record will be analyzed by Pediatric neurology faculty who are blinded to clinical status and Actigraphy scoring and reporting will be done
Complete evaluation of behavior ATEC CBCL CARS-2 sensory profile DP-3 and ABC will be done for all children undergoing screening polysomnography actigraphy on the same day
CARS is done to estimate the severity of autism It is different for high functioning children IQ 80 age 6 years with fluent speech with scores of 15-275 being minimal 28-335 mild to moderate and more than 34 is severe For other children age 6 years without fluent speech score of 15-295 15-275age for 13IQ80 is minimal 30-365 age 6 years without fluent speech 28-345age for 13IQ80 is mild to moderate and age 6 years without fluent speech score of 37 and higher score of 35 and higher age for 13IQ80 shows severe symptoms of Autism Spectrum Disorder The CARS is a 15-item scale used to grade the severity of autism in 14 behavioral domains
CBCL is used for determining the behavioral comorbidities The CBCL assesses behavior in 11 domains and there are two sets of questionnaires one for 15 to 5 years of age and another for 5 to 18 years of age which is separate for boys and girls
Development Profile 3 DP3 is used to estimate the development or intelligent quotient The DP3 assesses DQIQ in 5 domains Physical behavior Adaptive Behavior Cognition Social Emotional and Communication by parental reporting as well as direct observation
The Autism Treatment Evaluation Checklist ATEC was designed to assist parents physicians and researchers to evaluate virtually any treatment for autism It includes scoring in Speech Language Communication sociability sensory and cognitive awareness healthphysicalbehavior
The Autism Behavior Checklist ABC was designed to offer a method to more objectively identify autism in children The scale utilizes an observers rating of the childs behavior to quantify behaviors typically associated with Autism The ABC was developed as a clinical measure to screen for autism in individuals 3-35 years of age The scale was developed in 1980 and has not undergone revision since then The ABC consists of 57 items and 5 scales 1 Sensory 2 Relating 3 Body and Object use 4 Language and 5 Social and Self-help
If the child is found to have sleep disorder according to ICSD -3 criteria then they will be enrolled in the study after informed consent to undergo intervention
They will be given module-based intervention according to the disorder child is found to have
They will be followed up telephonically every 2 weeks and in OPDClinic every 4 weeks to ensure compliance with intervention
After 6 months of intervention CSHQ PSG and actigraphy evaluation of behavior ATEC CBCL CARS-2 sensory profile DP-3 and ABC will be repeated in the same method used before giving intervention
Pre and post CSHQ scores actigraphy and polysomnography behavioral scores will be compared and correlation between actigraphy and polysomnography will be measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None