An interventional study of HR-informed change in routine and Delayed HR-informed specific change in routine in Autism Spectrum Disorder, Intellectual Disability and Communication, Nonverbal, sponsored by University of Oslo. Recruiting at 2 sites in Norway. Open to participants aged 5 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by University of Oslo · Not applicable, Interventional, and Supportive care
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.
Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 38 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Having any disorder or any type of cancer with ongoing chemotherapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.
Behavioral: HR-informed change in routine
After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.
Behavioral: Delayed HR-informed specific change in routine
The intervention is given for a situation occuring at least ten times and accompanied by an increase in HR at least 80% of the time, during the two-week registration period. Change in care (intervention) is introduced from week 3. The intervention is in one of four forms: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.
The intervention is given for a situation occuring at least twenty times and accompanied by an increase in HR at least 80% of the time, during the four-week registration period. Change in care (intervention) is introduced from week 5. The intervention is in one of four forms: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.
Situations identified by 2 standard deviation increase in HR
The hypothesis is that a 2 standard deviation increase in HR can identify potentially painful care situations that require re-evaluation. Mean HR spike counts will be compared using a one-tailed paired sampled t-test to differentiate between suitable and unsuitable situations for care adjustments.
Time frame: 11 weeks
HRV (ms)
The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related biomarkers of HRV as evaluated at the beginning and the end of the study period.
Time frame: 6 weeks
Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)
The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related blood biomarkers (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) as evaluated at the beginning and the end of the study period.
Time frame: 6 weeks
Scores on quality of communication
The hypothesis is that HR as an aid in communication will increase caregivers' understanding of the patient as measured by changes in perceived understanding of the patient from the beginning to the end of the study period.
Time frame: 6 weeks
Plan to share: No
Started Feb 2023 (actual). Primary completion is estimated for Dec 2025, 34 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 34 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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