Clinical trial Recruiting at 2 sites Interventional Ages 5 to 70

Using heart rate to improve care for non-verbal patients

Official title: Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial

Run by University of Oslo · NCT05738278 · Data updated 2026-11-12

This study is testing if using heart rate data can help caregivers provide better and more comfortable care for non-verbal patients, like those with autism.

Quick facts

Study typeInterventional
Ages5 Years to 70 Years
SexAll
Enrollment38 (estimated)
SponsorUniversity of Oslo
Academic / other
Drugs / interventionschemotherapy
Locations2 sites (Oslo and 1 other locations)
StatusRecruiting
StartedFebruary 27, 2023
Main results expectedDecember 30, 2025
Study endsDecember 30, 2025
Registry record updatedJuly 4, 2025
Trial IDNCT05738278 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 5 to 70 with autism spectrum disorder and communication difficulties who reside in care facilities or attend specialized schools.

Probably not a fit

Patients with autoimmune disorders or those undergoing chemotherapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance the quality of care for non-verbal patients by utilizing heart rate (HR) data to identify and modify potentially painful care procedures. It will evaluate how HR can signal discomfort and assess the impact of HR-informed changes on pain biomarkers. Additionally, the study will explore how six weeks of communication through HR can improve interactions between patients and caregivers. The findings could lead to more compassionate and effective care strategies for individuals with autism and communication challenges.

Why it matters

Potential benefit: If successful, this approach could significantly reduce pain and improve communication for non-verbal patients.

How similar studies have gone: While the use of heart rate as a communication tool is innovative, similar studies have shown promise in improving care for patients with communication challenges.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Between 5 and 70 years of age at the time of data collection
* Autism spectrum disorder as evaluated by clinical psychologist
* Communication difficulties
* Living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school/day-care at least five days a week.
* Written informed consent is obtained from the subjects' legal representative.

Exclusion Criteria:

\- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.

Where it's running

  • Oslo University Hospital
    Oslo, Norway
    Recruiting
  • University of Oslo
    Oslo, Norway
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.