NCT05738278 Heart Rate Informed Changes in Care for Non-Communicating Patients
| NCT ID | NCT05738278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oslo |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2023-02-27 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.
Eligibility 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.
Contact & Investigator
Bjørnar Hassel
PRINCIPAL INVESTIGATOR
University of Oslo
Frequently Asked Questions
Who can join the NCT05738278 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 70 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05738278 currently recruiting?
Yes, NCT05738278 is actively recruiting participants. Contact the research team at bjornar.hassel@medisin.uio.no for enrollment information.
Where is the NCT05738278 trial being conducted?
This trial is being conducted at Oslo, Norway, Oslo, Norway.
Who is sponsoring the NCT05738278 clinical trial?
NCT05738278 is sponsored by University of Oslo. The principal investigator is Bjørnar Hassel at University of Oslo. The trial plans to enroll 38 participants.