NCT04955093

Heart Rate Variability Biofeedback in Young People With Autism

Completed NA Last updated 8 July 2021

What this trial tests

NA trial testing Biofeedback in Autistic Disorders Spectrum in 20 participants. Completed in 9 August 2017.

Timeline

30 May 2016

Primary endpoint
9 August 2017

9 August 2017

Quick facts

Lead sponsor	University of Ulster
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	30 May 2016
Primary completion	9 August 2017
Estimated completion	9 August 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• Biofeedback

Conditions studied

• Autistic Disorders Spectrum — all drugs for Autistic Disorders Spectrum →

Sponsor

University of Ulster

Who can join

Adults 13 to 24, any sex, with Autistic Disorders Spectrum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Heart Rate Variability Biofeedback to Treat Anxiety in Young People With Autism Spectrum Disorder: Findings From a Home-Based Pilot Study.
   Coulter H, Donnelly M, Mallett J, Kernohan WG. · · 2022 · cited 7× · PMID 36018712 · DOI 10.2196/37994