Not yet taking people in ChinaPhase 1/2

Inhaled xenon gas for children with autism spectrum disorder

Tests inhaled xenon on social skills in children with autism spectrum disorder.

Key facts

Who runs it: The Children's Hospital of Zhejiang University School of Medicine
Where: Hangzhou, ChinaSee the site
Trial code: NCT07435103
Registry title: Xenon Therapy for Children With Autism Spectrum Disorder
Status: Not yet recruiting
Phase: Phase 1/2
People taking part: 72 people, planned
Started: 1 Mar 2026
Expected to end: 30 Jun 2027
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Xenon
Record updated: 27 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with autism spectrum disorder to test whether inhaled xenon gas improves social functioning.

Age: 4 to 18 years
Sex: All sexes can join
Disease stage: Autism spectrum disorder confirmed by DSM-5 criteria and the ADOS-2 assessment, with a total T-score of 90 or more on the SRS-2 social scale.
Earlier treatment: No neuromodulation treatment (such as transcranial magnetic stimulation) for at least 1 month before randomization. Earlier psychotropic medicines must have been stopped for at least 5 half-lives or 4 weeks, whichever is longer. No new or changed treatments such as behavioral rehabilitation during the study.

Main reasons for not taking part

Other major neurological diseases such as epilepsy or cerebral palsy, severe physical illness, or genetic syndromes
Severe hearing or vision problems that prevent the assessments
Past severe allergic or other adverse reaction to Xenon
Taking part in other interventional trials within the last 3 months
Any condition the investigator judges to add risk or disturb the trial

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

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

Who cannot take part

Having other major neurological diseases (e.g., epilepsy, cerebral palsy), severe physical illnesses, or genetic syndromes
A history of anaphylaxis or adverse reactions to Xenon
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
Having severe auditory or visual impairments that prevent the completion of assessments with cooperation
Currently participating in or having participated in other interventional clinical trials within the recent 3 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 4 and 18 years old?

Where in China

Children's Hospital Affiliated to Zhejiang University School of Medicine (Binjiang Campus)Hangzhou, ChinaContact: Ai Mei MaNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

Participants inhaled 30% oxygen, 10 min/day, for 10 daysPlacebo, for comparison
Children aged 4-8 years with autism spectrum disorder in the control group underwent a daily 10-minute inhalation of 30% oxygen (delivered via face mask at 2 L/min) for 10 consecutive days.
Treatment: Xenon
Participants inhaled a mixture of 25% Xenon, 10 min/day, for 10 daysTreatment being tested
Children aged 4-8 years with autism spectrum disorder in the treatment group underwent a daily 10-minute inhalation of 25% Xenon (delivered via face mask at 2 L/min) for 10 consecutive days.
Treatment: Xenon