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Heart Rate Variability Biofeedback in Young People With Autism

NCT04955093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-08

No results posted yet for this study

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.

Conditions

  • Autistic Disorders Spectrum

Interventions

DEVICE

Biofeedback

Technology to provide Heart Rate Variability Biofeedback

Sponsors & Collaborators

  • South Eastern Health and Social Care Trust

    collaborator OTHER

  • University of Ulster

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
13 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-30
Primary Completion
2017-08-09
Completion
2017-08-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955093 on ClinicalTrials.gov