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Clinical Trials/NCT04319640
NCT04319640
Unknown
Not Applicable

the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy

Shanghai Jiao Tong University School of Medicine1 site in 1 country160 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
160
Locations
1
Primary Endpoint
congnitive-neural outcomes
Last Updated
6 years ago

Overview

Brief Summary

Sleep disturbance is very common in children with autism spectrum disorder (ASD),and closely associated with their core symptom, social deficit.This trial investigates the effects of Cognitive behaviour therapy for insomnia (CBT-I) in children with autism spectrum disorder with sleep problems through synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS). This is a 1:1 parallel single-blind randomized controlled trial.

Detailed Description

sleep disturbance is significantly associated with social deficit of ASD and but the congnitive-neural mechanism underlying this association remains unclear. Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia. After 5 consecutive sleep interventions is a 2-year following up study, the above issue is further tested with emphasis on progressive trajectory from a developmental perspective. we examine the influence of sleep disturbance on face processing and neural response during naturalistic social behavior of ASD children using synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social deficit.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Sijia Gu

staff of Research Department

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • meet the diagnostic criteria for autism DSM-5 and ADOS-2;
  • age 24months to 59months s old;
  • willing to participate in this study, and can complete the following assessments at the specific time.

Exclusion Criteria

  • Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;

Outcomes

Primary Outcomes

congnitive-neural outcomes

Time Frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds

The investigators examine the influence of sleep disorders on face processing and neural response at baseline, 6 months after the intervention, 12 months after the intervention and when children 6 year olds by synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social-emotional development.

ADOS-2

Time Frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds

The ADOS-2 is the standard instrument for assessing autism spectrum disorders (ASD) across age, developmental level, and language skills.

Secondary Outcomes

  • Sleep diaries by using Actigraphy(changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds)

Study Sites (1)

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