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

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Ce qui est testé

RSA biofeedback

Dispositif médical
Qui peut participer

Trouble du Spectre de l'Autisme+1

+ Troubles Mentaux

+ Troubles Envahissants du Développement

De 13 à 18 ans
+11 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Groupe Placebo
Interventionnel
Date de début : novembre 2020
Voir le détail du protocole

Résumé

Sponsor principalUniversitaire Ziekenhuizen KU Leuven
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 26 novembre 2020

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielEvaluating the Potential of Respiratory-sinus-arrhythmia Biofeedback for Reducing Physiological Stress in Adolescents With Autism: a Randomized Controlled Study
Sponsor principalUniversitaire Ziekenhuizen KU Leuven
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

63 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 13 à 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Trouble du Spectre de l'AutismeTroubles MentauxTroubles Envahissants du DéveloppementTroubles du développement neurologique

Critères

4 critères d'inclusion nécessaires pour participer
13-18 years old

Written informed consent/assent

Male/female

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

7 critères d'exclusion empêchent la participation
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

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

3 groupes d'intervention sont désignés dans cette étude

33,333% de chances d'être dans le groupe placebo en aveugle

Groupes de traitement

Groupe I

Expérimental
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.

Groupe II

Expérimental
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.

Groupe III

Dispositif fictif
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.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

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Cette étude comporte 1 site

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KU Leuven

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