The Children's Hospital of Zhejiang University School of Medicine
Phase
Phase 1/2
Started
2026-03-01
Last updated
2026-02-27
Condition(s) studied
Autism Spectrum Disorder (ASD)Autism
Investigational drug(s) / intervention(s)
Xenon
Xenon: Children aged 4-18 with autism spectrum disorder inhaled a mixture of 25% Xenon via a face mask at an oxygen flow rate of 2 L/min, for 10 minutes per day for 10 day.
Study summary
This study aims to evaluate the efficacy and safety of inhaled xenon for the treatment of children with autism spectrum disorder (ASD). The primary objective is to determine whether short-term inhalational xenon therapy can improve social functioning in children with ASD, as measured by changes in the Social Responsiveness Scale (SRS). Safety and tolerability of xenon inhalation in the pediatric population will also be assessed.
In this randomized, placebo-controlled trial, participants will receive either inhaled xenon or a placebo gas (medical air without xenon) to compare treatment effects.
Participants will:
Inhale 25% xenon or placebo for 10 minutes per day for 10 consecutive days Attend two clinical visits: one immediately after completion of the intervention and one at 3 months post-intervention for follow-up assessments and safety evaluations
Eligibility
Sex
ALL
Min age
4 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 4-18 years, with no gender restriction.
* Meeting the diagnostic criteria for Autism Spectrum Disorder (ASD) as specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with the diagnosis confirmed by assessment using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).
* The total T-score on the Social Responsiveness Scale, Second Edition (SRS-2) is ≥90.
* No treatment such as neuromodulation (transcranial magnetic stimulation, transcranial electrical stimulation) has been received for at least 1 month prior to randomization.
* For participants who have previously taken psychotropic medications prior to randomization, it is required that the medications have been discontinued for a minimum of 5 half-lives or 4 weeks, whichever is longer.
* The participants and their legal guardians confirm that they will not add new or alter the existing established treatment regimens such as behavioral rehabilitation during the study period.
* The legal guardians of the participants have a full understanding of the study content, participate voluntarily, and sign a written informed consent form.
Exclusion Criteria:
* Having other major neurological diseases (e.g., epilepsy, cerebral palsy), severe physical illnesses, or genetic syndromes.
* Having severe auditory or visual impairments that prevent the completion of assessments with cooperation.
* A history of anaphylaxis or adverse reactions to Xenon.
* Currently participating in or having participated in other interventional clinical trials within the recent 3 months.
* The investigator judges that there is any condition that may increase the risk to the participant or interfere with the conduct of the trial and the assessment of its results.
Primary outcome measure(s)
Core symptom outcomes — From enrollment to the end of treatment at 3 months. For the assessment of core symptom outcomes, the social responsiveness scale, Second Edition was used.Raw scores were converted to age- and sex-normed T-scores, with a minimum obtainable T-score of 30. A total T-score of 60 or higher indicates clinically significant symptom severity, whereas T-scores of 59 or below are considered within the normal range.
Trial sites (1)
Facility
City
Region
Status
Children's Hospital Affiliated to Zhejiang University School of Medicine (Binjiang Campus)
Hangzhou
Zhejiang
More The Children's Hospital of Zhejiang University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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