Tracking daily movement and sleep in children with autism
Official title: Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism
Run by IRCCS San Raffaele Roma · NCT07519369 · Data updated 2026-11-12
This project tests whether wearable sensors and home sleep recordings can capture everyday movement and sleep patterns in children and teens with autism.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | February 18, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07519369 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 2–18 years with a DSM-5 diagnosis of autism who can walk independently, tolerate wearing a wrist sensor and insoles, and whose parents can consent to a week of monitoring and one night of home polysomnography are ideal candidates.
✕Probably not a fit
Children with severe motor impairments, severe behavior that prevents device use despite acclimatization, skin conditions preventing wristband wear, recent orthopedic surgery, or who require orthoses during walking are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The research uses wearable wrist sensors, pedobarographic insoles, and markerless video tools to monitor gait and daily activity in natural settings over several days, combined with one night of home polysomnography with video-EEG/polygraphy. Children will wear the devices continuously for a week and undergo a reproducible gait assessment in clinic alongside home sleep recording. Collected data on movement, gait, and sleep will be integrated and compared with measures of sensory processing to identify patterns and relationships. The work aims to create more personalized and accessible ways to characterize motor and sleep differences in autism that could inform care.
Why it matters
Potential benefit: If successful, this approach could help families and clinicians understand each child's movement and sleep patterns so care and interventions can be better tailored.
How similar studies have gone: Actigraphy and markerless video approaches have shown promise for long-term monitoring of activity and sleep, but combining these with home polysomnography and pedobarographic gait assessment in ASD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria * Age between 2 and 18 years * Ability to walk independently * Willingness to wear a wearable device (wrist sensor) continuously for 7 days and pedobarographic insoles for reproducible gait monitoring * Willingness to undergo one night of home polysomnography with video-EEG/polygraphy during the wearable monitoring period * Informed consent signed by both parents/legal guardian; assent from the minor when applicable Exclusion Criteria: * Skin contraindications to the wristband/fixation systems (known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use) * Severe motor impairments * Recent orthopedic surgery (\<6 months) * Use of orthoses or assistive devices during walking * Severe behavioral disorder making device use impracticable despite acclimatization strategies
Where it's running
-
IRCCS San Raffaele
Roma, Rm, Italy Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Clown therapy to help kids with autism sit for dental visits
This study tests whether clown therapy can help children with autism sit through a dental examination more easily than conventional familiarization methods.
-
French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls
This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.
-
Cardiorespiratory and muscular fitness in children with obesity and autism
This study tests whether cardiorespiratory fitness and handgrip strength differ between children with obesity who have autism and those who do not, and how these fitness measures relate to body size, composition, and cardiometabolic health.
-
Transitional Intervention for Hyperacusis in Autism
Aiming to see if a transitional sound-therapy approach can help adults with autism tolerate everyday sounds better and reduce loudness-related distress.
-
Museum visits to support social and emotional well‑being in autistic adults
This study tests whether visiting the National Taiwan Museum can help improve social participation and well-being for autistic adults aged 18–50.
-
AdiaVita and glutathione for autism in kids and teens
This study tests whether adding AdiaVita (cord-blood stem cells and exosomes) to glutathione helps improve ASD symptoms in children and other participants compared with glutathione alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.