Suspended

Evaluating the Potential of Respiratory-sinus-arrhythmia Biofeedback for Reducing Physiological Stress in Adolescents With Autism: a Randomized Controlled Study

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What is being tested

RSA biofeedback

Device
Who is being recruted

Autism Spectrum Disorder+1

+ Mental Disorders

+ Child Development Disorders, Pervasive

From 13 to 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: November 2020
See protocol details

Summary

Principal SponsorUniversitaire Ziekenhuizen KU Leuven
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 26, 2020

Actual date on which the first participant was enrolled.

In recent years, numerous studies have investigated the potential contributing role of the autonomic nervous system (ANS) in psychiatric disorders, including autism spectrum disorder (ASD). One of the most commonly adopted physiological parameters for assessing ANS functioning in psycho-physiological research is based on the assessment of heart rate variability (HRV). The heart's pacemaker is controlled by both the sympathetic and the parasympathetic nervous system, which results in the natural variation of the interval between heart beats. One important component of HRV is commonly known as respiratory sinus arrhythmia (RSA). This component is solely mediated by the parasympathetic subsystem through direct projections of the vagus nerve from the brain stem to the heart and is therefore also known as an index of cardiac vagal modulation. The term RSA is adopted since it defines the phenomenon of the relation between heart rate variability and the respiratory cycle in certain circumstances. The clinical importance of RSA has been reported in multiple studies as higher RSA is associated with higher cognitive abilities, effective social behavior, fewer internalizing symptoms (e.g. anxiety and depression) and appropriate emotion regulation. In addition, lower RSA has been linked to conduct problems, trait hostility, anxiety disorders and depression. With respect to children and adolescents with ASD, several studies have investigated the ANS functioning by assessing RSA during various activities (e.g. cognitive tasks, non-social auditory tasks, social cognition tasks and social interaction tasks) as well as during resting situations. While some studies revealed no significant differences in RSA levels between ASD and typically developing (TD) peers, the majority of studies seemed to converge on demonstrating lower levels of RSA in patients with ASD. Furthermore, in these studies, lower RSA levels in ASD were associated with more social problems, internalizing problems, higher levels of anxiety, problems with emotional control, the presence of more severe visual and/or auditory sensory problems and the presence of repetitive and restrictive behaviors. In line with the link between lowered RSA and more psychological and social problems, it has been posited that it would be of great relevance to develop and validate an intervention that specifically targets the up-regulation of RSA-values, or the cardiac vagal modulation, in individuals with ASD . To do so, biofeedback-based interventions have been put forward as these involve the recording of physiological signals (e.g. RSA or skin conductance) which are transformed into visual (or auditory) presentations and subsequently provided to the individual as direct feedback. This visualisation of ongoing bodily sensations would provide an added value for individuals with ASD, as previous studies have reported a lower ability to consciously perceive internal bodily sensations (interoceptive awareness) in this population. Considering that adolescence is a vulnerable period with rapid changes in distinct developmental domains, this population will be targeted during this research project. As previously mentioned, the clinical importance of RSA in both typically developing populations and populations with ASD has already been demonstrated. However, due to methodological differences, these studies are frequently incomparable and/or often lead to conflicting evidence. Therefore, a cross-sectional phase will be conducted first in this research project in which adolescents with and without ASD will be recruited. In this phase, they will perform a stress-inducing test in which physiological, endogenic and behavioral data will be collected. The main focus of this first part is on RSA in which lower RSA-values are hypothesized in adolescents with ASD as compared to their typically developing peers, based on previously mentioned study results. The second part of this research project consists of the evaluation of an RSA-based biofeedback approach for the up-regulation of RSA in adolescents with ASD. In other words, we will explore the potential of this intervention for enhancing cardiac vagal modulation and the influence on behavioral problems related to lower RSA in individuals with ASD as determined in previous research and based on findings during the first part of this study. Importantly, the validation of an RSA biofeedback intervention for adolescents with ASD may open novel avenues for home-based interventions in this population where therapist contact can be limited and integration into the daily routine can be supported using biofeedback apps. In addition, the current worldwide circumstances due to the corona virus disease has provided clinicians with new and useful information regarding their patients with ASD as these patients perceived the increase of home-based interventions as something positive. Therefore, the biofeedback intervention in this research project may have an additional advantage due to its home-based approach. Finally, the promising results of RSA biofeedback interventions in clinical populations, including ASD, are reported in various domains, going from decrements in anxiety and depression symptoms to improvements of social functioning. Therefore, this intervention may be valuable for adolescents with ASD given their vulnerable position in development.

Official TitleEvaluating the Potential of Respiratory-sinus-arrhythmia Biofeedback for Reducing Physiological Stress in Adolescents With Autism: a Randomized Controlled Study
Principal SponsorUniversitaire Ziekenhuizen KU Leuven
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

63 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Criteria

4 inclusion criteria required to participate
13-18 years old

Written informed consent/assent

Male/female

For adolescents with ASD only: Confirmed ASD-diagnosis (DSM-IV/V)

7 exclusion criteria prevent from participating
Presence of intellectual disability (DSM-IV/V)

Hearing- or vision impairment without appropriate correction

Presence of congenital heart diseases, diagnosed cardiovascular abnormalities or somatic diseases

Pregnancy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
1 short guided session (30 minutes) and daily practice (20 minutes; 4 bouts of 5 minutes) for 5 weeks. The biofeedback protocol will be provided by an application, similar to the supervised protocol but without guidance throughout the sessions, except for the first session. During this first session, the information will be provided about the application and the heart rate sensor (Polar band) which will detect changes in heart rate during the training. In addition, the resonance frequency of the participant will be determined so they can practice breathing at this frequency for the next 5 weeks.

Group II

Experimental
5 weeks with weekly supervised sessions of 30 minutes and daily home practice sessions of 20 minutes. The latter sessions can be divided into four bouts of 5 minutes which can be spread across the day. The main goal during this intervention is to breath at resonance frequency which is slower than the usual breathing frequency. Participants will be guided towards this lower breathing frequency by using appropriate breathing techniques and the provision of a breathing pacer during the supervised sessions. During home practice, the participants will be provided with an application which will visualise a breathing pacer at their resonance frequency. At the third session, participants will no longer receive a breathing pacer but are instructed to breath in phase with their heart rate which is visualised on the computer screen instead of the breathing pacer.

Group III

Sham
5 weeks with weekly supervised sessions of 30 minutes and daily home practice sessions of 20 minutes. The latter sessions can be divided into four bouts of 5 minutes which can be spread across the day. The sham-control treatment will follow the same steps as outlined in the supervised intervention arm. However, the participants in this control group will not receive any information regarding their own heart rate and they will not practice at their resonance frequency. Instead, a default mode will be shown during the sessions and in their application for home practice.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

KU Leuven

Leuven, BelgiumOpen KU Leuven in Google Maps
SuspendedOne Study Center