Tracking daily movement and sleep in children with autism
Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT07519369 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, RM
- IRCCS San Raffaele — Roma, Rm, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.