Autism Spectrum Disorder (ASD)Phase 1/2ASD; XeNCT07435103
Xenon Therapy for Children With Autism Spectrum Disorder
A Phase 1/2 study testing Xenon in people with Autism Spectrum Disorder (ASD) and Autism, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Autism
- What is being tested?
- Xenon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's Hospital Affiliated to Zhejiang University School of Medicine (Binjiang Campus)
Hangzhou, Zhejiang, 310000
Ai Mei Ma, 0571-86029132, zuchiec@163.com
About this study
Official title: Efficacy of Xenon in Children With Autism Spectrum Disorder: a Multicenter, Randomized, Controlled Study
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.
Read more
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
- Being tested
- Xenon
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called Xe
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 3 months.
Secondary outcomes (7)
Core symptom outcomes
For the assessment of core symptom outcomes, the Autism Diagnostic Observation Schedule (ADOS-2) was used.
Measured: From enrollment to the end of treatment at 3 months.
Aberrant behavior outcomes
For the assessment of aberrant behavior outcomes, the Aberrant behavior Checklist (ABC) scale was used.
Measured: From enrollment to the end of treatment at 3 months.
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.
Measured: From enrollment to the end of treatment at 3 months.
Severity
For the assessment of behavioral severity, the Clinical Impressions Severity of illness (CGI-S) was used.
Measured: From enrollment to the end of treatment at 3 months.
Improvements
For the assessment of behavioral improvements after treatment, the Clinical Global Impressions scale for Improvement (CGI-I) scale was used.The Clinical Global Impressions-Improvement scale is a 7-point scale ranging from 1 ("Very much improved") to 7 ("Very much worse"), with a score of 4 indicating "No change."
Measured: From enrollment to the end of treatment at 3 months.
Sleep problems
For the assessment of sleep problems, the Children's Sleep Habits Questionnair (CSHQ) was used.
Measured: From enrollment to the end of treatment at 3 months.
Brain functions
For the assessment of brian functions, the MRI imaging was used.
Measured: From enrollment to the end of treatment at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daqing Ma, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435103
- Sponsor's protocol ID
- 2026-IRB-0023-IR-01
- Other IDs
- CHZJU2025IIT006
- Acronym
- ASD; Xe
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Xenon in Children With Autism Spectrum Disorder: a Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07435103
- Acronym / sponsor ID
- ASD; Xe / 2026-IRB-0023-IR-01
- Conditions
- Autism Spectrum Disorder (ASD), Autism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants inhaled 30% oxygen, 10 min/day, for 10 days | Placebo comparator | Drug: XenonChildren 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. |
| Participants inhaled a mixture of 25% Xenon, 10 min/day, for 10 days | Experimental | Drug: XenonChildren 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonAlso: XeChildren 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. | Drug | Participants inhaled 30% oxygen, 10 min/day, for 10 days, Participants inhaled a mixture of 25% Xenon, 10 min/day, for 10 days |
Primary outcome
Core symptom outcomes
Time frame: From enrollment to the end of treatment at 3 months.
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.
7 secondary outcomes
Core symptom outcomes
Time frame: From enrollment to the end of treatment at 3 months.
Aberrant behavior outcomes
Time frame: From enrollment to the end of treatment at 3 months.
Treatment efficacy
Time frame: From enrollment to the end of treatment at 3 months.
Severity
Time frame: From enrollment to the end of treatment at 3 months.
Improvements
Time frame: From enrollment to the end of treatment at 3 months.
Sleep problems
Time frame: From enrollment to the end of treatment at 3 months.
Brain functions
Time frame: From enrollment to the end of treatment at 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xenon in people with Autism Spectrum Disorder (ASD) and Autism, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin piao Zhu, Associate fellow (0571-81732399, zhujinpiao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core symptom outcomes (time frame: From enrollment to the end of treatment at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.