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Can a nasal spray help autism symptoms? new study investigates

NCT ID NCT07521371

Knowledge-focused Sponsor: Healing Hope International Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows about 12 children and young adults (ages 4 to 21) with autism who are already using intranasal insulin as part of their regular care. Researchers want to see if this treatment is safe and if it helps with social skills, communication, and behavior over 6 months. No new treatment is given—the study just observes what happens in real life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study population includes approximately 12 children and young adults (ages 4 to 21 years) with a clinical diagnosis of autism spectrum disorder (ASD). Participants are individuals who are using or planning to use intranasal insulin as prescribed by their treating healthcare providers as part of routine clinical care. The population represents a real-world sample of individuals with ASD across a range of functional abilities and symptom severity. Caregivers are involved in reporting outcomes related to social communication, behavior, and adaptive functioning. Participants are followed prospectively for approximately 6 months in a non-interventional, observational setting.

Ages

4 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 4 to 21 years * Clinical diagnosis of autism spectrum disorder (ASD) documented by a qualified healthcare provider * Currently using or planning to use intranasal insulin as prescribed by a treating healthcare provider as part of routine clinical care * Stable medical and behavioral therapy regimen for at least 4 weeks prior to baseline (if applicable) * Caregiver or parent/guardian able to provide informed consent and complete study related assessments * Willingness to participate in observational data collection over approximately 6 months Exclusion Criteria: * Known diagnosis of diabetes mellitus requiring insulin for glycemic control * History of recurrent hypoglycemia or clinically significant risk of hypoglycemia * Known hypersensitivity or adverse reaction to insulin * Significant uncontrolled medical conditions that, in the opinion of the investigator, would interfere with participation or data interpretation * Use of investigational drugs or participation in an interventional clinical trial within 30 days prior to enrollment * Any condition that would prevent reliable participation in study assessments, including inability of caregiver to complete questionnaires

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder neurodevelopmental disorder pervasive developmental disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Autism spectrum disorder (ASD) Autism spectrum disorder high-functioning Autism spectrum disorder with absence of functional language Autism spectrum disorder with impaired functional language Autistic disorder Autistic disorder in children and adolescents Autistic disorder of childhood onset with full syndrome Autistic disorders spectrum Neurodevelopmental disorders Neurodevelopmental disorders (NDD) Neurodevelopmental disorders and developmental abnormalities

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Healing Hope International

    Spring, Texas, 77386, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.