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

March 5, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University

The Involvement of Sleep Spindle Waves in the Auxiliary Diagnosis of Social Memory Disorders in Children With Autism Spectrum Disorders

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Afflicated Hospital Xian Jiaotong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ASD group
Diagnosed as ASD based on DSM-V diagnostic criteria and combined with clinical manifestations.
Diagnostic test: social memory levels and spindle levels
Take a face recognition memory test, and a car recognition memory test as a control . Then record nighttime EEG recordings after the two tasks and performed subsequent spindle analysis.So conduct the correlation between social memory levels and the level of spindles in the EEG by using machine learning to model.
Control group
Healthy children
Diagnostic test: social memory levels and spindle levels
Take a face recognition memory test, and a car recognition memory test as a control . Then record nighttime EEG recordings after the two tasks and performed subsequent spindle analysis.So conduct the correlation between social memory levels and the level of spindles in the EEG by using machine learning to model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recognition accuracy
Time Frame: 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).
Through face & car recognition task completion, an average of 2-4 days.
Response delay time
Time Frame: 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.
Through face & car recognition task completion, an average of 2-4 days.
Sleep spindle density
Time Frame: 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.
Through the 12 hour EEG recording completion, an average of 5-12 days.
Sleep spindle average duration
Time Frame: Through the 12 hour EEG recording completion, an average of 5-12 days.
Calculate the average duration (s) of single spindle.
Through the 12 hour EEG recording completion, an average of 5-12 days.
Sleep spindle amplitude
Time Frame: 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.
Through the 12 hour EEG recording completion, an average of 5-12 days.
Sleep spindle frequency
Time Frame: 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.
Through the 12 hour EEG recording completion, an average of 5-12 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Xi'an TCM Hospital of Encephalopathy

Investigators

  • Study Director: Yan Li, PhD, First Afflicated Hospital of Xian Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2023LSK-481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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