Sleep Disorders Trial, Recruiting NCT07519369 Sponsor: IRCCS San Raffaele Roma Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07519369
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The person has been diagnosed with autism spectrum disorder (ASD) based on standard medical criteria (DSM-5)
  • The person is between 2 and 18 years old
  • The person is able to walk on their own without assistance
  • The person and their family are willing to have them wear a wrist sensor device continuously for 7 days, along with special insoles inside their shoes to monitor how they walk
  • The person and their family are willing to have them undergo one overnight sleep study at home, using monitoring equipment, during the same 7-day period
  • Both parents or legal guardians have signed a consent form agreeing to participation; if the child is old enough to understand, their own agreement is also required

Who may not be able to join:

  • The person has a skin condition, known allergy to the device materials, a rash, or skin sores on their wrist that would make wearing the wrist sensor uncomfortable or harmful
  • The person has serious physical difficulties with movement or motor control
  • The person has had surgery on bones or joints within the last 6 months
  • The person uses leg braces, splints, or any walking aids during daily movement
  • The person has significant behavioural challenges that would make wearing the devices too difficult, even after attempts to help them get used to the equipment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
IRCCS San Raffaele Roma
Registry
ClinicalTrials.gov
Start date
18 February 2026
Est. completion
1 June 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov