Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04955093 |
| Other study ID # |
IRAS139122 |
| Secondary ID |
15/NI/0255 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2016 |
| Est. completion date |
August 9, 2017 |
Study information
| Verified date |
June 2021 |
| Source |
University of Ulster |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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
1. To provide a home based HRV biofeedback intervention to people with autistic spectrum
disorder.
2. To collect data from participants and their carers on participant anxiety, depression
and physiological arousal before and after using a biofeedback device.
3. To assess the adoption of HRV biofeedback technology in terms of user acceptance and
levels of dropout.
4. To evaluate the risks and benefits of this technology in terms of stress management.
5. 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.
