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NCT Number: NCT07435103

Xenon Therapy for Children With Autism Spectrum Disorder

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

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Children's Hospital Affiliated to Zhejiang University School of Medicine (Binjiang Campus)

Hangzhou, Zhejiang, 310000, China

Location contact

Ai Mei Ma

CONTACT

[email protected]

0571-86029132

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xenon

Drug

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.

Other names: Xe

Primary outcomes

  1. Core symptom outcomes

    Time frame: 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.

Secondary outcomes

  1. Core symptom outcomes

    Time frame: From enrollment to the end of treatment at 3 months.

    For the assessment of core symptom outcomes, the Autism Diagnostic Observation Schedule (ADOS-2) was used.

  2. Aberrant behavior outcomes

    Time frame: From enrollment to the end of treatment at 3 months.

    For the assessment of aberrant behavior outcomes, the Aberrant behavior Checklist (ABC) scale was used.

  3. Treatment efficacy

    Time frame: From enrollment to the end of treatment at 3 months.

    For the assessment of treatment efficacy, the Autism Treatment Evaluation Checklist scale was used. The Autism Treatment Evaluation Checklist total score ranges from a minimum of 0 (no autism symptoms) to a maximum of 179 (severe impairment), with lower scores indicating fewer symptoms and higher scores indicating greater severity.

  4. Severity

    Time frame: From enrollment to the end of treatment at 3 months.

    For the assessment of behavioral severity, the Clinical Impressions Severity of illness (CGI-S) was used.

  5. Improvements

    Time frame: From enrollment to the end of treatment at 3 months.

    For the assessment of behavioral improvements after treatment, the Clinical Global Impressions scale for Improvement (CGI-I) scale was used.The Clinical Global Impressions-Improvement scale is a 7-point scale ranging from 1 ("Very much improved") to 7 ("Very much worse"), with a score of 4 indicating "No change."

  6. Sleep problems

    Time frame: From enrollment to the end of treatment at 3 months.

    For the assessment of sleep problems, the Children's Sleep Habits Questionnair (CSHQ) was used.

  7. Brain functions

    Time frame: From enrollment to the end of treatment at 3 months.

    For the assessment of brian functions, the MRI imaging was used.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin piao Zhu, Associate fellow

CONTACT

[email protected]

0571-81732399

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Acronym: ASD; Xe

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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