Autism Spectrum DisorderNCT05738278
Heart Rate Informed Changes in Care for Non-Communicating Patients
A study testing HR-informed change in routine and Delayed HR-informed specific change in routine in people with Autism Spectrum Disorder and Intellectual Disability, run by University of Oslo at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Autism Spectrum Disorder, Intellectual Disability, Communication, Nonverbal
- What is being tested?
- HR-informed change in routine and Delayed HR-informed specific change in routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesNorway
- Study dates
- 27 Feb 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0192
Bjørnar Hassel, Professor
- Recruiting
University of Oslo
Oslo, 0450
Bjørnar Hassel, PhD, 004798829754, bjornar.hassel@medisin.uio.no
Emilie SM Kildal, 004745481949, eskildal@uio.no
About this study
Official title: Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
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.
Read the detailed description
Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42
- Being tested
- HR-informed change in routine, Delayed HR-informed specific change in routine
- Keywords
- Heart Rate, Autistic Disorder, Intellectual Disability, Social Interaction, Caregivers, Developmental Disabilities, Communication, Biomarkers, Pain
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability, Nonverbal Communication, Autistic Disorder, Developmental Disabilities, Communication, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-informed change in routineBehavioural
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:
- changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,
- preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,
- change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or
- revised personal hygiene procedure.
Delayed HR-informed specific change in routineBehavioural
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:
- changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,
- preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,
- change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or
- revised personal hygiene procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3. Receives: Behavioral: HR-informed change in routine |
| Control group | Active comparator | After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5. Receives: Behavioral: Delayed HR-informed specific change in routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start27 Feb 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Thirty-eight non-verbal patients are recruited. HR is taken as a marker of acute pain. HR-Variability (HRV) and pain-related inflammatory cytokines (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) are collected as measures of long-term pain. Caregivers will be asked to what degree they observe pain in their patients and how well they believe they understand their patient's expression. Collection is set to primary care institutions. HR is measured 8 hours/day over 2 weeks to identify increase of HR associated with potentially painful situations. Changes in procedures are in the form of change in 1) rigorousness of stretching, 2) preparations for casts, 3) lifting technique, or 4) personal hygiene procedure. To differentiate effects due to procedure-change from effects of covariates such as increased attentiveness when using HR; half the study group will start intervention in week 3 while the delayed group will continue data collection for another 2 weeks before introducing procedure changes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjørnar Hassel, University of Oslo
- Investigators
- Bjørnar Hassel, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738278
- Sponsor's protocol ID
- #2016/1956
- Status last verified
- Jul 2025
- First submitted
- 27 Oct 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kildal E, Stadskleiv K, Boysen ES, Oderud T, Dahl IL, Seeberg TM, Guldal S, Strisland F, Morland C, Hassel B. Increased heart rate functions as a signal of acute distress in non-communicating persons with intellectual disability. Sci Rep. 2021 Mar 19;11(1):6479. doi: 10.1038/s41598-021-86023-6.
PubMed 33742078Kildal ESM, Quintana DS, Szabo A, Tronstad C, Andreassen O, Naerland T, Hassel B. Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2023 Apr 14;23(1):252. doi: 10.1186/s12888-023-04757-1.
PubMed 37060049
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05738278
- Acronym / sponsor ID
- #2016/1956
- Keywords
- Heart Rate, Autistic Disorder, Intellectual Disability, Social Interaction, Caregivers, Developmental Disabilities, Communication, Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty-eight non-verbal patients are recruited. HR is taken as a marker of acute pain. HR-Variability (HRV) and pain-related inflammatory cytokines (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) are collected as measures of long-term pain. Caregivers will be asked to what degree they observe pain in their patients and how well they believe they understand their patient's expression. Collection is set to primary care institutions. HR is measured 8 hours/day over 2 weeks to identify increase of HR associated with potentially painful situations. Changes in procedures are in the form of change in 1) rigorousness of stretching, 2) preparations for casts, 3) lifting technique, or 4) personal hygiene procedure. To differentiate effects due to procedure-change from effects of covariates such as increased attentiveness when using HR; half the study group will start intervention in week 3 while the delayed group will continue data collection for another 2 weeks before introducing procedure changes.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: HR-informed change in routineAfter 2 weeks mapping phase, patient-specific HR-informed intervention from week 3. |
| Control group | Active comparator | Behavioral: Delayed HR-informed specific change in routineAfter 4 weeks mapping phase, patient-specific HR-informed intervention from week 5. |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR-informed change in routineThe 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. | Behavioural | Intervention group |
| Delayed HR-informed specific change in routineThe 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. | Behavioural | Control group |
Primary outcome
Situations identified by 2 standard deviation increase in HR
Time frame: 11 weeks
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.
3 secondary outcomes
HRV (ms)
Time frame: 6 weeks
Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)
Time frame: 6 weeks
Scores on quality of communication
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 33742078Kildal E, Stadskleiv K, Boysen ES, Oderud T, Dahl IL, Seeberg TM, Guldal S, Strisland F, Morland C, Hassel B. Increased heart rate functions as a signal of acute distress in non-communicating persons with intellectual disability. Sci Rep. 2021 Mar 19;11(1):6479. doi: 10.1038/s41598-021-86023-6.
- Derived from this study: PubMed 37060049Kildal ESM, Quintana DS, Szabo A, Tronstad C, Andreassen O, Naerland T, Hassel B. Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2023 Apr 14;23(1):252. doi: 10.1186/s12888-023-04757-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bjørnar Hassel principal investigator
University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-informed change in routine and Delayed HR-informed specific change in routine in people with Autism Spectrum Disorder and Intellectual Disability, run by University of Oslo at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bjørnar Hassel, Professor (0047 98829754, bjornar.hassel@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Situations identified by 2 standard deviation increase in HR (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05738278, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.