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Not yet recruiting NCT07435103

Xenon Therapy for Children With Autism Spectrum Disorder

Phase I / Phase II Interventional Autism Spectrum Disorder (ASD) Autism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xenon.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder (ASD), Autism. Basic parameters: 4 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Xenon in Children With Autism Spectrum Disorder: a Multicenter, Randomized, Controlled Study

Overview

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

Interventions

  • Drug 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.

Primary outcome measures

  • Core symptom outcomes [Time frame: From enrollment to the end of treatment at 3 months.]
Secondary outcome measures (7)
  • Core symptom outcomes [Time frame: From enrollment to the end of treatment at 3 months.]
  • Aberrant behavior outcomes [Time frame: From enrollment to the end of treatment at 3 months.]
  • Treatment efficacy [Time frame: From enrollment to the end of treatment at 3 months.]
  • Severity [Time frame: From enrollment to the end of treatment at 3 months.]
  • Improvements [Time frame: From enrollment to the end of treatment at 3 months.]
  • Sleep problems [Time frame: From enrollment to the end of treatment at 3 months.]
  • Brain functions [Time frame: From enrollment to the end of treatment at 3 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Children's Hospital Affiliated to Zhejiang University School of Medicine (Binjiang Campus) — Hangzhou

Identifiers

NCT: NCT07435103 · 2026-IRB-0023-IR-01 · CHZJU2025IIT006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗