Clinical trial NCT06306378: The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder
Official title: The Involvement of Sleep Spindle Waves in the Auxiliary Diagnosis of Social Memory Disorders in Children With Autism Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: Sleep spindles
Social Memory Deficits
Diagnosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xi'an TCM Hospital of Encephalopathy
First posted: 2024-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is expected to recruit 60 participants aged 6-18, of which 30 in the case group are all inpatient and outpatient cases from Xi'an Traditional Chinese Medicine Brain Disease Hospital, and are designated as ASD according to unified diagnostic standards; The healthy control group consists of 30 individuals from nearby community kindergartens and primary schools at Xi'an Traditional Chinese Medicine Brain Disease Hospital, who have not suffered from ASD or other diseases related to ASD research factors.

Brief summary: Research background and project basis

Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.

Research purpose

Exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD.

Detailed description: The goal of this observational study is to exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with autism spectrum disorders(ASD). The main question it aims to answer is the effect of sleep spindles on social memory. The study clinically recruited 30 children with ASD and 30 normal children. Participants will be asked to take face and car recognition memory tests which car recognition memory test as a control. After the two tasks, nighttime EEG recordings and subsequent spindle analysis will be recorded and performed.Then the correlation analysis between social memory levels and spindle levels would be conducted by machine learning model, so that researchers can infer the individual's social memory level through the level of spindles in the EEG.

Eligibility criteria: Inclusion Criteria:

* Children with ASD diagnosed through DSM-V (Healthy controls do not have this requirement)
* IQ score ≥ 75（WISC-IV，Wechsler Intelligence Scale for Children）
* Age: 6-18
* Not receiving psychotropic medication (Or stopping medication for at least 2 weeks before the experiment)

Exclusion Criteria:

* In addition to ASD, other mental illnesses are also combined
* Presence of a sleep disorder, sleep apnea, periodic leg movements during sleep, or atypical EEG patterns
* Left handed

Primary outcomes:
measure: Recognition accuracy
timeFrame: Through face & car recognition task completion, an average of 2-4 days.
measure: Response delay time
timeFrame: Through face & car recognition task completion, an average of 2-4 days.
measure: Sleep spindle density
timeFrame: Through the 12 hour EEG recording completion, an average of 5-12 days.
measure: Sleep spindle average duration
timeFrame: Through the 12 hour EEG recording completion, an average of 5-12 days.
measure: Sleep spindle amplitude
timeFrame: Through the 12 hour EEG recording completion, an average of 5-12 days.
measure: Sleep spindle frequency
timeFrame: Through the 12 hour EEG recording completion, an average of 5-12 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Afflicated Hospital Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Afflicated Hospital of Xian Jiaotong University
name: Yan Li, PhD
role: STUDY_DIRECTOR
References:
citation: Lai M, Lee J, Chiu S, Charm J, So WY, Yuen FP, Kwok C, Tsoi J, Lin Y, Zee B. A machine learning approach for retinal images analysis as an objective screening method for children with autism spectrum disorder. EClinicalMedicine. 2020 Nov 5;28:100588. doi: 10.1016/j.eclinm.2020.100588. eCollection 2020 Nov.
citation: Georgescu AL, Koehler JC, Weiske J, Vogeley K, Koutsouleris N, Falter-Wagner C. Machine Learning to Study Social Interaction Difficulties in ASD. Front Robot AI. 2019 Nov 29;6:132. doi: 10.3389/frobt.2019.00132. eCollection 2019.
citation: Das S, Zomorrodi R, Mirjalili M, Kirkovski M, Blumberger DM, Rajji TK, Desarkar P. Machine learning approaches for electroencephalography and magnetoencephalography analyses in autism spectrum disorder: A systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2023 Apr 20;123:110705. doi: 10.1016/j.pnpbp.2022.110705. Epub 2022 Dec 24.