NCT07435103

Xenon Therapy for Children With Autism Spectrum Disorder

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-30
• Completion: 2027-06-30
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China