Xenon Therapy for Children With Autism Spectrum Disorder
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-18
SponsorThe Children's Hospital of Zhejiang University School of Medicine
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Xenon
DrugChildren 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Participants inhaled 30% oxygen, 10 min/day, for 10 daysPlacebo comparator 1 intervention
Group B: Participants inhaled a mixture of 25% Xenon, 10 min/day, for 10 daysExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 3 months.Secondary outcomes
1
Core symptom outcomes
For the assessment of core symptom outcomes, the Autism Diagnostic Observation Schedule (ADOS-2) was used.
Time frame
From enrollment to the end of treatment at 3 months.2
Aberrant behavior outcomes
For the assessment of aberrant behavior outcomes, the Aberrant behavior Checklist (ABC) scale was used.
Time frame
From enrollment to the end of treatment at 3 months.3
Treatment efficacy
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.
Time frame
From enrollment to the end of treatment at 3 months.4
Severity
For the assessment of behavioral severity, the Clinical Impressions Severity of illness (CGI-S) was used.
Time frame
From enrollment to the end of treatment at 3 months.Sponsors and contacts
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Source ClinicalTrials.gov
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