Autistic Disorders SpectrumNCT04955093
Heart Rate Variability Biofeedback in Young People With Autism
A study testing Biofeedback in people with Autistic Disorders Spectrum, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Biofeedback is a process that allows people to obtain information about their internal physiological reactions and thereby learn to control them. Researchers studying the brain and nervous system have found that regulating heart rate can help us to relax. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Autistic Disorders Spectrum
- What is being tested?
- Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2016to 9 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of High functioning autism / Asperger's syndrome using standardized tests (ADOS / ADI / DISCO), IQ over 70, English speaker Existing or previous client resident within South Eastern Health \& Social Care Trust catchment area.
Who cannot join
- Learning disability (IQ<70). Cardiac condition / pacemaker. Drug /alcohol addiction Current psychosis Current suicidal ideation. Eczema / psoriasis Immunosuppressing condition MRSA / C Difficile
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Eastern Health Trust
Belfast, Northern Ireland, BT37 0QB
About this study
Official title: An Investigation Into the Use of Heart Rate Variability Biofeedback in People With Autistic Spectrum Disorder
Biofeedback is a process that allows people to obtain information about their internal physiological reactions and thereby learn to control them.
Researchers studying the brain and nervous system have found that regulating heart rate can help us to relax. Controlling heart rate using biofeedback has been shown in some studies to help people manage symptoms of stress such as anxiety and depression.
Read more
This research will explore whether biofeedback can help people with autism or Asperger syndrome reduce reported symptoms of stress.
Participants with a diagnosis of high functioning autism will be invited to use a biofeedback device that helps them to regulate their heart rate. People who enrol for the study will be randomly assigned different biofeedback devices. Training and support in the use of the device will be provided to participants.
Assessment will involve obtaining questionnaire reports from participants and their carers about participant levels of anxiety, depression and sensory symptoms, demographics and lifestyle. These assessments will be carried out at the beginning, in the middle and at the end of the study to see if there are any differences in how each participant's heart rate changes, whether there are any changes in participant's reported symptoms. Participants will be asked to give daily reports on their progress to monitor stress levels, usability of device and dropout rates. The overall aim is to determine whether biofeedback is a way of helping people with autism to reduce symptoms of stress.
Read the detailed description
Based on a review of the literature, it is hypothesised that HRV biofeedback could offer a means to help regulate ANS dysfunction and symptoms such as anxiety \& depression in people with autistic spectrum disorder. To date, no studies have been identified which report on the pre post measurement of HRV in autism using a longitudinal design. Furthermore, to date, no published studies have reported on the use of portable HRV biofeedback devices as a potential intervention for individuals with autism to help manage symptoms such as anxiety \& depression.
An initial usability evaluation has been carried out and approved by Ulster University faculty of Life \& Health sciences in 2014 to determine the timings required to undertake the assessment and assess usability of equipment, measures, physiological assessment sensors and recording of data (see appendix I for a summary). The current study aims to assess the feasibility of employing a technology intervention for people with autism using small portable HRV biofeedback devices to help manage symptoms such as anxiety. Because of the differences in physiology seen in many people with autism, any study aiming to understand a potential new intervention for this population should include pre and post intervention assessments of they react physiologically and respond to information. This study will therefore use pre and post questionnaire assessment from participants and their carers, but will also record participant's heart rate variability pre and post intervention to assess any changes in participants underlying physiology.
Aim To understand the use of heart rate variability biofeedback in people with autistic spectrum disorder.
Objectives
- To provide a home based HRV biofeedback intervention to people with autistic spectrum disorder.
- To collect data from participants and their carers on participant anxiety, depression and physiological arousal before and after using a biofeedback device.
- To assess the adoption of HRV biofeedback technology in terms of user acceptance and levels of dropout.
- To evaluate the risks and benefits of this technology in terms of stress management.
- To develop recommendations on the use of HRV biofeedback for people with autistic spectrum disorder.
Methodology The study will follow the revised MRC guidelines for the development and evaluation of complex interventions, namely a feasibility and piloting study which will look at dropout rates, test methodology and procedure, and determine the size of sample that would eventually be needed to obtain estimates of effect size in a full scale randomised trial.
Design The study is essentially a clinical trial that involves a detailed follow up of a sample of people with autistic spectrum disorder (n=39, IQ>70) using repeated measures in a randomised control experimental design.
- Conditions
- Autistic Disorders Spectrum
- Being tested
- Biofeedback
- Medical subject headings
- Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackDevice
Technology to provide Heart Rate Variability Biofeedback
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Biofeedback |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Anxiety Scale using Beck Youth Inventory
10-15 minute Questionnaire
Measured: At baseline, after six weeks and at end-point at 12 weeks
Secondary outcomes (1)
Any change in Heart rate variability (ideally key metrics increased)
Physiological recording of heart rate variability using single lead ECG
Measured: At baseline, after six weeks and at end-point at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start30 May 2016
- Primary completion9 Aug 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic Disorders SpectrumStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Feasibility study to test out methodology prior to any future large scale trial. It involves a detailed follow up of a clinical sample of people with highfunctioning autism, using repeated measures in a randomized control experimental design. Intervention participants will be given a biofeedback device and training immediately, whilst the control group will wait 6 weeks and then receive the intervention. This will help to increase participation and maximize the detailed data collection that is required
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- South Eastern Health and Social Care Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955093
- Sponsor's protocol ID
- IRAS139122
- Other IDs
- 15/NI/0255
- Status last verified
- Jun 2021
- First submitted
- 19 Sep 2017
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
Coulter H, Donnelly M, Mallett J, Kernohan WG. Heart Rate Variability Biofeedback to Treat Anxiety in Young People With Autism Spectrum Disorder: Findings From a Home-Based Pilot Study. JMIR Form Res. 2022 Aug 26;6(8):e37994. doi: 10.2196/37994.
PubMed 36018712
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Use of Heart Rate Variability Biofeedback in People With Autistic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04955093
- Acronym / sponsor ID
- IRAS139122
- Conditions
- Autistic Disorders Spectrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- South Eastern Health and Social Care Trust
- Study start
- 30 May 2016 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 8 Jul 2021 (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.
Biofeedback is a process that allows people to obtain information about their internal physiological reactions and thereby learn to control them.
Researchers studying the brain and nervous system have found that regulating heart rate can help us to relax. Controlling heart rate using biofeedback has been shown in some studies to help people manage symptoms of stress such as anxiety and depression.
This research will explore whether biofeedback can help people with autism or Asperger syndrome reduce reported symptoms of stress.
Participants with a diagnosis of high functioning autism will be invited to use a biofeedback device that helps them to regulate their heart rate. People who enrol for the study will be randomly assigned different biofeedback devices. Training and support in the use of the device will be provided to participants.
Assessment will involve obtaining questionnaire reports from participants and their carers about participant levels of anxiety, depression and sensory symptoms, demographics and lifestyle. These assessments will be carried out at the beginning, in the middle and at the end of the study to see if there are any differences in how each participant's heart rate changes, whether there are any changes in participant's reported symptoms. Participants will be asked to give daily reports on their progress to monitor stress levels, usability of device and dropout rates. The overall aim is to determine whether biofeedback is a way of helping people with autism to reduce symptoms of stress.
Detailed description
Based on a review of the literature, it is hypothesised that HRV biofeedback could offer a means to help regulate ANS dysfunction and symptoms such as anxiety \& depression in people with autistic spectrum disorder. To date, no studies have been identified which report on the pre post measurement of HRV in autism using a longitudinal design. Furthermore, to date, no published studies have reported on the use of portable HRV biofeedback devices as a potential intervention for individuals with autism to help manage symptoms such as anxiety \& depression.
An initial usability evaluation has been carried out and approved by Ulster University faculty of Life \& Health sciences in 2014 to determine the timings required to undertake the assessment and assess usability of equipment, measures, physiological assessment sensors and recording of data (see appendix I for a summary). The current study aims to assess the feasibility of employing a technology intervention for people with autism using small portable HRV biofeedback devices to help manage symptoms such as anxiety. Because of the differences in physiology seen in many people with autism, any study aiming to understand a potential new intervention for this population should include pre and post intervention assessments of they react physiologically and respond to information. This study will therefore use pre and post questionnaire assessment from participants and their carers, but will also record participant's heart rate variability pre and post intervention to assess any changes in participants underlying physiology.
Aim To understand the use of heart rate variability biofeedback in people with autistic spectrum disorder.
Objectives
- To provide a home based HRV biofeedback intervention to people with autistic spectrum disorder.
- To collect data from participants and their carers on participant anxiety, depression and physiological arousal before and after using a biofeedback device.
- To assess the adoption of HRV biofeedback technology in terms of user acceptance and levels of dropout.
- To evaluate the risks and benefits of this technology in terms of stress management.
- To develop recommendations on the use of HRV biofeedback for people with autistic spectrum disorder.
Methodology The study will follow the revised MRC guidelines for the development and evaluation of complex interventions, namely a feasibility and piloting study which will look at dropout rates, test methodology and procedure, and determine the size of sample that would eventually be needed to obtain estimates of effect size in a full scale randomised trial.
Design The study is essentially a clinical trial that involves a detailed follow up of a sample of people with autistic spectrum disorder (n=39, IQ>70) using repeated measures in a randomised control experimental design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility study to test out methodology prior to any future large scale trial. It involves a detailed follow up of a clinical sample of people with highfunctioning autism, using repeated measures in a randomized control experimental design. Intervention participants will be given a biofeedback device and training immediately, whilst the control group will wait 6 weeks and then receive the intervention. This will help to increase participation and maximize the detailed data collection that is required
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Biofeedback |
| Control | No intervention | – |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of High functioning autism / Asperger's syndrome using standardized tests (ADOS / ADI / DISCO), IQ over 70, English speaker Existing or previous client resident within South Eastern Health \& Social Care Trust catchment area.
Key exclusion criteria (1 listed)
- Learning disability (IQ<70). Cardiac condition / pacemaker. Drug /alcohol addiction Current psychosis Current suicidal ideation. Eczema / psoriasis Immunosuppressing condition MRSA / C Difficile
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 |
|---|---|---|
| BiofeedbackTechnology to provide Heart Rate Variability Biofeedback | Device | Intervention |
Primary outcome
Reduction in Anxiety Scale using Beck Youth Inventory
Time frame: At baseline, after six weeks and at end-point at 12 weeks
10-15 minute Questionnaire
1 secondary outcome
Any change in Heart rate variability (ideally key metrics increased)
Time frame: At baseline, after six weeks and at end-point at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 36018712Coulter H, Donnelly M, Mallett J, Kernohan WG. Heart Rate Variability Biofeedback to Treat Anxiety in Young People With Autism Spectrum Disorder: Findings From a Home-Based Pilot Study. JMIR Form Res. 2022 Aug 26;6(8):e37994. doi: 10.2196/37994.
- Individual participant dataSharing planned: No. No IPD will be shared
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Autistic Disorders Spectrum, run by University of Ulster at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Anxiety Scale using Beck Youth Inventory (time frame: At baseline, after six weeks and at end-point at 12 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 NCT04955093, which also lists 1 linked publication.
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 8 Jul 2021.