The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Diagnostic Test: social memory levels and spindle levels

• Registration Number: NCT06306378
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-12-04
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-03-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD group	social memory levels and spindle levels	Diagnosed as ASD based on DSM-V diagnostic criteria and combined with clinical manifestations.
Control group	social memory levels and spindle levels	Healthy children

Primary Outcome Measures

Name	Time	Method
Sleep spindle density	Through the 12 hour EEG recording completion, an average of 5-12 days.	Sleep spindle wave recognition and data processing use the YASA (Yet Another Spindle Algorithm) toolbox based on Python to stage EEG sleep automatic recognition of sleep spindle waves. Calculate the density (N/min) of sleep spindles.
Sleep spindle amplitude	Through the 12 hour EEG recording completion, an average of 5-12 days.	Amplitude (μV) refers to the maximum energy value possessed by the spindle wave.
Response delay time	Through face & car recognition task completion, an average of 2-4 days.	Reaction time is commonly used to evaluate cognitive abilities. Mean reaction times (ms) were calculated for correct responses (hits), which is the response delay time.
Sleep spindle average duration	Through the 12 hour EEG recording completion, an average of 5-12 days.	Calculate the average duration (s) of single spindle.
Sleep spindle frequency	Through the 12 hour EEG recording completion, an average of 5-12 days.	Frequency (Hz) refers to the number of times the spindle wave vibrates repeatedly per second.
Recognition accuracy	Through face & car recognition task completion, an average of 2-4 days.	Recognition accuracy as an evaluation indicator for cars and facial recognition.; The car and face recognition task included a learning phase on the first night (approximately 30 minutes before going to bed) and a recognition test phase on the second morning (approximately 30 minutes after waking up). The learning phase included 11 pictures of adult faces (319 × 432 pixel). During the learning phase, pictures were randomly presented for 3s with an inter-stimulus interval of 2s. During the test phase, two pictures were presented simultaneously, with the picture from the study list (called "old") paired with an unseen picture (called "new"), in random left-right order. Participants were asked to select a picture they had seen previously by pressing the left and right buttons. And the next stimulus was presented immediately after the participant answered. Recognition accuracy was computed as the number of correct responses (hits).

Trial Locations

Locations (1)

First Afflicated Hospital Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China