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Xenon Therapy for Children With Autism Spectrum Disorder

NCT07435103 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-27

No results posted yet for this 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

Conditions

  • Autism Spectrum Disorder (ASD)
  • Autism

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.

Sponsors & Collaborators

  • The Children's Hospital of Zhejiang University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-03-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435103 on ClinicalTrials.gov