NCT07435103

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

February 5, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 5, 2026

Last Update Submit

February 24, 2026

Conditions

Autism Spectrum Disorder (ASD)Autism

Outcome Measures

Primary Outcomes (1)

  • Core symptom outcomes

    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.

    From enrollment to the end of treatment at 3 months.

Secondary Outcomes (7)

  • Core symptom outcomes

    From enrollment to the end of treatment at 3 months.

  • Aberrant behavior outcomes

    From enrollment to the end of treatment at 3 months.

  • Treatment efficacy

    From enrollment to the end of treatment at 3 months.

  • Severity

    From enrollment to the end of treatment at 3 months.

  • Improvements

    From enrollment to the end of treatment at 3 months.

  • +2 more secondary outcomes

Study Arms (2)

Participants inhaled 30% oxygen, 10 min/day, for 10 days

PLACEBO COMPARATOR

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.

Drug: Xenon

Participants inhaled a mixture of 25% Xenon, 10 min/day, for 10 days

EXPERIMENTAL

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.

Drug: Xenon

Interventions

XenonDRUG

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.

Also known as: Xe
Participants inhaled 30% oxygen, 10 min/day, for 10 daysParticipants inhaled a mixture of 25% Xenon, 10 min/day, for 10 days

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

Xenon

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGases

Central Study Contacts

Jin piao Zhu, Associate fellow

CONTACT

0571-81732399zhujinpiao@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)