Autism Spectrum Disorder
Conditions
Interventions
Xe group:Participants in the treatment group 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 d.
Control group:Participants in the control group inhaled 30% oxygen via a face mask at an oxygen flow rate of 2 L/min, for 10 minutes per day for 10 consecutive days
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 4–18 years, with no gender restriction. 2. 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). 3. The total T-score on the Social Responsiveness Scale, Second Edition (SRS-2) is >=90. 4. No treatment such as neuromodulation (transcranial magnetic stimulation, transcranial electrical stimulation) has been received for at least 1 month prior to randomization. 5. 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. 6. 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. 7. The legal guardians of the participants have a full understanding of the study content, participate voluntarily, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Having other major neurological diseases (e.g., epilepsy, cerebral palsy), severe physical illnesses, or genetic syndromes. 2. Having severe auditory or visual impairments that prevent the completion of assessments with cooperation. 3. A history of anaphylaxis or adverse reactions to Xe. 4. Currently participating in or having participated in other interventional clinical trials within the recent 3 months. 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcomes of Core Symptoms in Autism Spectrum Disorder; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements;Sleep problems;Treatment efficacy;Severity;Aberrant behavior outcomes;Brain functions;Core symptom outcomes; | — |
Countries
China
Contacts
Public ContactJinpiao Zhu
Children's Hospital,Zhejiang University School of Medicine
Outcome results
None listed