Autism Spectrum DisorderNCT06306378
The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Research background and project basis Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- social memory levels and spindle levels
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Afflicated Hospital Xian Jiaotong University
Xi'an, Shaanxi, 710061
Yan Li, MD., PhD., 13720418610, liyanxjtu@xjtu.edu.cn
Dongqi Cui, PhD., 18501059233, 18501059233@163.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- social memory levels and spindle levels
- Keywords
- Sleep spindles, Social Memory Deficits, Diagnosis
- Medical subject headings
- Autism Spectrum Disorder, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social memory levels and spindle levelsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| ASD group | Diagnosed as ASD based on DSM-V diagnostic criteria and combined with clinical manifestations. Receives: Diagnostic Test: social memory levels and spindle levels | |
| Control group | Healthy children Receives: Diagnostic Test: social memory levels and spindle levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition accuracy
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).
Measured: Through face & car recognition task completion, an average of 2-4 days.
Response delay time
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.
Measured: Through face & car recognition task completion, an average of 2-4 days.
Sleep spindle density
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.
Measured: Through the 12 hour EEG recording completion, an average of 5-12 days.
Sleep spindle average duration
Calculate the average duration (s) of single spindle.
Measured: Through the 12 hour EEG recording completion, an average of 5-12 days.
Sleep spindle amplitude
Amplitude (μV) refers to the maximum energy value possessed by the spindle wave.
Measured: Through the 12 hour EEG recording completion, an average of 5-12 days.
Sleep spindle frequency
Frequency (Hz) refers to the number of times the spindle wave vibrates repeatedly per second.
Measured: Through the 12 hour EEG recording completion, an average of 5-12 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 Dec 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an TCM Hospital of Encephalopathy
- Responsible party
- Sponsor
- Investigators
- Yan Li, PhD, Study director, First Afflicated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306378
- Sponsor's protocol ID
- XJTU1AF2023LSK-481
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33294809Georgescu 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.
PubMed 33501147Das 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.
PubMed 36574922
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Involvement of Sleep Spindle Waves in the Auxiliary Diagnosis of Social Memory Disorders in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06306378
- Acronym / sponsor ID
- XJTU1AF2023LSK-481
- Conditions
- Autism Spectrum Disorder
- Keywords
- Sleep spindles, Social Memory Deficits, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xi'an TCM Hospital of Encephalopathy
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Diagnostic Test: social memory levels and spindle levelsDiagnosed as ASD based on DSM-V diagnostic criteria and combined with clinical manifestations. |
| Control group | – | Diagnostic Test: social memory levels and spindle levelsHealthy children |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| social memory levels and spindle levelsTake 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. | Diagnostic test | ASD group, Control group |
Primary outcome
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).
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 33294809Lai 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.
- Background: PubMed 33501147Georgescu 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.
- Background: PubMed 36574922Das 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Li, PhD study director
First Afflicated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongqi Cui, PhD (18501059233, 18501059233@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition accuracy (time frame: Through face & car recognition task completion, an average of 2-4 days.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306378, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.