AutismPEACE-ANCT07238153
Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism
A study testing Guided breathing exercise - SPB and Guided breathing exercise - HRV-BF in people with Autism and Autism Spectrum Disorder, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
This study examines the impact of guided breathing exercises on stress and heart rate variability (HRV) in autistic young adults. It explores how daily movement behavior (sleep, physical activity and sedentary behavior) influences HRV and to what extent two guided breathing exercises can affect HRV. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Guided breathing exercise - SPB and Guided breathing exercise - HRV-BF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesBelgium
- Study dates
- 30 Nov 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For participants ≥18 years a voluntary written informed consent and for participants < 18 years a written informed consent from the parents or their legally authorized representative and an informed assent of the participant has been obtained prior to any screening procedures
- Male or Female (biological)
- Between 16 and 25 years old
- Diagnosis of autism as described in the DSM-IV/DSM-5(-TR)
Who cannot join
- Participant has a history of congenital heart diseases, diagnosed cardiovascular abnormalities or somatic diseases conditions that may interfere with the main outcome measure HRV or with the safe practice of breathing exercises (e.g., uncontrolled epilepsy, severe respiratory illness)
- Presence of contra-indications for participating (intervention and/or assessment): acute agitation and/or severe psychiatric symptoms (psychosis, mania or major depression) and/or active substance use.
- The presence of an intellectual disability, defined as an intelligence quotient < 70, as described in the DSM-IV/DSM-V.
- Insufficient knowledge of Dutch language in order to follow instructions and fill out questionnaires.
- Female who is pregnant.
- Participation in another interventional study, with or without an investigational medicinal product (IMP) or device (IMD).
- The use of medication known to affect cardiac modulation (excluding hormonal contraceptives).
- Hearing- or vision impairment that cannot be corrected to normal functioning.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams Brabant, 3000
Esther Meers, +323 479976850, esther.meers@kuleuven.be
Davy Vancampfort, Prof. dr.
- Not yet recruiting
UPC Z.Org
Leuven
Esther Meers, +32 479976850, esther.meers@kuleuven.be
Tine Van Damme, Prof. dr., tine.vandamme@kuleuven.be
About this study
This study examines the impact of guided breathing exercises on stress and heart rate variability (HRV) in autistic young adults. It explores how daily movement behavior (sleep, physical activity and sedentary behavior) influences HRV and to what extent two guided breathing exercises can affect HRV. Additionally, the study investigates how participants perceive the exercises in terms of usability and usefulness.
Read the detailed description
For many autistic individuals, transitioning into adulthood can be challenging and stressful. This stress often affects their mental health. The autistic community has highlighted the need for better mental health support, including accessible and effective ways to manage stress. Among the non-pharmacological interventions aimed at improving mental health via stress reduction, guided breathing interventions are promising, also on a psychophysiological level. During a stressful situation, internal regulatory processes take place to maintain balance, starting by activating the autonomic nervous system (ANS). Prior work indicates that a dysfunction of the ANS contributes to the heightened mental health challenges observed in autistic individuals. Heart rate variability (HRV), the variation in time between heartbeats, is an physiological index of the functioning of the ANS. The Neurovisceral Integration Theory highlights the role of parasympathetic regulation of the heart rate, associating higher vagally mediated HRV with better health, emotional regulation and executive functioning.In autistic individuals, the overall levels of cardiac vagal modulation are lower compared to neurotypical peers.
To date, research investigating the potential of interventions aimed at increasing HRV in autistic individuals is scarce. Moreover, HRV is influenced by several aspects (e.g., sleep, physical activity) and knowledge on their combined impact is necessary to understand how HRV can be used in research and clinical practice. Therefore, in this project, the investigators will explore the role of physical activity, sedentary behavior, and sleep on HRV and determine what constitutes a significant change in HRV.
The investigators will also examine the psychophysiological effects, feasibility, and acceptability of the two leading protocols in guided breathing interventions (heart rate variability biofeedback and slow-paced breathing). HRV-BF optimizes HRV by guiding individuals to breathe at their resonance frequency, synchronizing heart rate and breathing. SPB prescribes to breathe at a fixed pace of 6 breaths per minute.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Guided breathing exercise - SPB, Guided breathing exercise - HRV-BF
- Keywords
- Heart rate variability, Stress, Biofeedback, Autism, Movement behavior, Guided breathing exercise, slow paced breathing
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided breathing exercise - SPBDevice
Guided breathing exercises are performed at a fixed pace of 6 breaths per minute (SPB) .
Guided breathing exercise - HRV-BFDevice
Guided breathing exercises are performed at each participant's individually determined resonance frequency, which typically falls between 4.5 and 7 breaths per minute (HRV-BF).
| Study group | Role | What they receive |
|---|---|---|
| Slow paced breathing (SPB) | Active comparator | The participants will receive a 5-week training, starting with one visit to explain the procedure and determine the individual resonance frequency (for reasons of comparison). Afterwards, participants are instructed to practice at home, using the Pebbles. The breathing frequency of the Pebbles will be set at 6 breaths/minute (3-1-4-2) (slow-paced breathing) and participants are instructed to practice 4x5 minutes a day. In week 2 and week 3, follow-up sessions will be scheduled with each participant (in line with the protocol for the HRV-BF group). Similar to the HRV-BF group, the participants will be asked to rate the level of comfort during the training via a secure web-based application (m-path, KU Leuven) and compliance and physiological data will be captured with the Pebbles. The device used to support the home-based training. Receives: Device: Guided breathing exercise - SPB |
| Heart rate variability biofeedback (HRV-BF) | Active comparator | The participants will follow a fixed scheme: consisting of 3 supervised sessions (30 minutes) combined with home-practice on the other days (20 minutes, 4x5 minutes/day), followed by a training period of 2 weeks, without supervised sessions. In the first session, the personal resonance frequency of the participant will be determined. The resonance frequency refers to a breathing frequency between 4.5 and 7 breaths per minute at which heart rate and the breathing pattern are in phase, also known as Respiratory Sinus Arrhythmia. This introductory session is followed by two supervised training session in week 2 and 3. The participants will be asked to rate the level of comfort during the training via a secure web-based application (m-path, KU Leuven) and compliance and physiological data will be captured with the Pebbles. The device used to support the home-based training. Receives: Device: Guided breathing exercise - HRV-BF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac vagal modulation of heart rate based on resting-state HRV.
Calculated as (1) a time domain measure (RMSSD: Root Mean Square of Successive Differences). Three-lead electrocardiographic data will be captured using the NeXus-10 MKII biofeedback device and Biotrace+ Software (MindMedia B.V., The Netherlands). Disposable, self-adhesive and pre-gelled electrodes (Kendall™ ECG Electrodes Arbo™ H124SG, Covidien, Ireland) will be used without specific skin preparations at a sampling rate of 256 SPS. For the recording of the breathing frequency, an elastic band with stretch-sensitive sensors and a sampling rate of 32 SPS is placed around the waist.
Measured: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Change in cardiac vagal modulation of heart rate based on resting-state HRV
Calculated as (2) a frequency domain measures (HF-HRV). Three-lead electrocardiographic data will be captured using the NeXus-10 MKII biofeedback device and Biotrace+ Software (MindMedia B.V., The Netherlands). Disposable, self-adhesive and pre-gelled electrodes (Kendall™ ECG Electrodes Arbo™ H124SG, Covidien, Ireland) will be used without specific skin preparations at a sampling rate of 256 SPS. For the recording of the breathing frequency, an elastic band with stretch-sensitive sensors and a sampling rate of 32 SPS is placed around the waist.
Measured: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Secondary outcomes (10)
Change in mental health indicators
(1) Symptom Checklist-90 Revised (SCL-90-R): The Dutch version measures eight dimensions: anxiety (ANG), agoraphobia (AGO), depression (DEP), somatization (SOM), cognitive-performance deficits (IN), interpersonal sensitivity and mistrust (SEN), hostility (HOS), and sleep difficulties (SLA). Each item is rated on a 5-point Likert scale from 1 ("not at all") to 5 ("extremely"). The total score ranges from 90 to 450. The total score provides a general measure of psychological distress. Higher scores indicate more symptoms and distress.
The scores on the eight dimensions range for ANG between 10 and 50, for AGO between 7 and 35, for DEP between 16 and 80, for SOM between 12 and 60, for IN between 9 and 45, for SEN between 18 and 90, for HOS between 6 and 30 and for SLA between 3 and 15. Higher scores indicate more symptoms and distress.
Measured: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Change in mental health indicators
(2) Depression Anxiety Stress Scales (DASS-21): The Dutch version of the DASS-21 measures the presence of symptoms of depression, anxiety, and stress. In consists of 21 items and takes about 10 minutes to complete. Each item is rated on a 4-point Likert scale from 0 ("did not apply to me at all") to 3 ("applied to me very much, or most of the time"). The scale yields three subscale scores: Depression, Anxiety, and Stress, each based on 7 items. Subscale scores therefore range from 0 to 21. To calculate the scores, the subscale scores are multiplied by two, resulting in a final range of 0 to 42 per subscale. Higher scores indicate greater symptom severity.
Measured: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Change in mental health indicators
(3) Perceived stress scale (PSS-10): The Dutch version of the PSS measures the degree to which situations in one's life are appraised as stressful, that is, how unpredictable, uncontrollable, and overloaded respondents experience their lives. It consists of 10 items and takes maximum 5 minutes to complete. Each item is rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often"). Four items are positively stated and are reverse-scored (item 4,5,7 en 8). Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress
Measured: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
feasibility and acceptability of the HRV-BF and SPB interventions.
The investigators will explore how participants experience the guided breathing protocols, including their usability. This aspect will be assessed through a self-report questionnaire, including the registration of perceived stress before and after each sessions, using a Visual Analogue Scale (VAS) ranging from "none" to "a lot".
Measured: For 5 weeks 4 times per day (before and after each sessions) during the intervention phase (between week 5 and week 10)
feasibility and acceptability of the HRV-BF and SPB interventions.
The investigators will explore how participants experience the guided breathing protocols, including their acceptability. This aspect will be assessed through a self-report questionnaire, including the registration of the overall experience of each session, using a Visual Analogue Scale (VAS) after each session going form "very unpleasant" to "very pleasant".
Measured: For 5 weeks 4 times per day during the intervention phase (between week 5 and week 10)
feasibility and acceptability of the HRV-BF and SPB interventions.
The investigators will explore how participants experience the guided breathing protocols, including their, safety. This aspect will be assessed though self-report questionnaires, including the registration of adverse events and mild negative reactions.
Measured: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.
feasibility and acceptability of the HRV-BF and SPB interventions.
The investigators will explore how participants experience the guided breathing protocols, including their, safety. This aspect will be assessed though through observations and contact with the investigator during the guided intervention sessions
Measured: During the guided intervention sessions at week 5, 6 and 7.
feasibility and acceptability of the HRV-BF and SPB interventions.
The investigators will explore how participants experience the guided breathing protocols, including their, safety. This aspect will be assessed though the registration of adverse events and mild negative reactions.
Measured: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.
feasibility and acceptability of the HRV-BF and SPB interventions.
The investigators will explore how participants experience the guided breathing protocols, including their acceptability, safety, usability and adaptability to daily life. These aspects will be assessed through in-depth interviews. The interview guide was developed based on the Theoretical Framework of Acceptability (TFA). This framework allows for a comprehensive exploration of intervention acceptability through seven key constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy).
Measured: At time point 3 (week 15) during the follow-up assessment
Feasibility and acceptability of the HRV-BF and SPB interventions.
The investigators will explore how participants experience the guided breathing protocols, including their usability. This aspect will be assessed through a self-report questionnaire, namely: the System Usability Scale (SUS), which will provide insight into the usability of the digitally delivered home-based training. Each item will be scored on a five-point Likert scale ranging from "strongly disagree" to "strongly agree. The item scores are summed to calculate the total SUS score, which ranges from 0 to 100, representing the overall system usability. Overall scores from 0 to 50 indicate "not acceptable," 51 to 70 indicate marginal level of usability, and 71 to 100 indicate "acceptable" levels of usability.
Measured: At time point 3 (week 15) during the follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start30 Nov 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study begins with an assessment at T0, followed by a five-week baseline period. The assessment consist of a physiological measurement and three mental health questionnaires. During the baseline period, all participants will wear an accelerometer to monitor their movement behaviors. The accelerometer will be wrist worn for 7 consecutive days. After this baseline period, participants will be randomly assigned to one of two intervention groups (HRV- biofeedback or slow-paced breathing) and the second assessment will take place at T1. The following intervention period lasts five weeks. During this period, all participants will receive 3 supervised sessions with the researcher, combined with home-based practice. After the intervention period the third assessment will take place at T2. Following the intervention, there will be a five-week no-intervention period for all participants. After this, a follow-up assessment will take place at T3.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tine Van Damme, Prof. dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238153
- Sponsor's protocol ID
- S70725
- Acronym
- PEACE-A
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (demographics, primary and secondary outcome measures, adverse events) will be shared. No directly identifying information will be included. The interview questions will be shared, but interview responses will not be made available in order to protect participant privacy. The study protocol, the statistical analysis plan, analytic code, and a blank informed consent form will be shared. The de-identified dataset will be accompanied by clear documentation explaining the variables, coding, and outcome measures so that researchers can interpret the data without access to the full protocol or analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism
- ClinicalTrials.gov ID
- NCT07238153
- Acronym / sponsor ID
- PEACE-A / S70725
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- Heart rate variability, Stress, Biofeedback, Autism, Movement behavior, Guided breathing exercise, slow paced breathing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the impact of guided breathing exercises on stress and heart rate variability (HRV) in autistic young adults. It explores how daily movement behavior (sleep, physical activity and sedentary behavior) influences HRV and to what extent two guided breathing exercises can affect HRV. Additionally, the study investigates how participants perceive the exercises in terms of usability and usefulness.
Detailed description
For many autistic individuals, transitioning into adulthood can be challenging and stressful. This stress often affects their mental health. The autistic community has highlighted the need for better mental health support, including accessible and effective ways to manage stress. Among the non-pharmacological interventions aimed at improving mental health via stress reduction, guided breathing interventions are promising, also on a psychophysiological level. During a stressful situation, internal regulatory processes take place to maintain balance, starting by activating the autonomic nervous system (ANS). Prior work indicates that a dysfunction of the ANS contributes to the heightened mental health challenges observed in autistic individuals. Heart rate variability (HRV), the variation in time between heartbeats, is an physiological index of the functioning of the ANS. The Neurovisceral Integration Theory highlights the role of parasympathetic regulation of the heart rate, associating higher vagally mediated HRV with better health, emotional regulation and executive functioning.In autistic individuals, the overall levels of cardiac vagal modulation are lower compared to neurotypical peers.
To date, research investigating the potential of interventions aimed at increasing HRV in autistic individuals is scarce. Moreover, HRV is influenced by several aspects (e.g., sleep, physical activity) and knowledge on their combined impact is necessary to understand how HRV can be used in research and clinical practice. Therefore, in this project, the investigators will explore the role of physical activity, sedentary behavior, and sleep on HRV and determine what constitutes a significant change in HRV.
The investigators will also examine the psychophysiological effects, feasibility, and acceptability of the two leading protocols in guided breathing interventions (heart rate variability biofeedback and slow-paced breathing). HRV-BF optimizes HRV by guiding individuals to breathe at their resonance frequency, synchronizing heart rate and breathing. SPB prescribes to breathe at a fixed pace of 6 breaths per minute.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study begins with an assessment at T0, followed by a five-week baseline period. The assessment consist of a physiological measurement and three mental health questionnaires. During the baseline period, all participants will wear an accelerometer to monitor their movement behaviors. The accelerometer will be wrist worn for 7 consecutive days. After this baseline period, participants will be randomly assigned to one of two intervention groups (HRV- biofeedback or slow-paced breathing) and the second assessment will take place at T1. The following intervention period lasts five weeks. During this period, all participants will receive 3 supervised sessions with the researcher, combined with home-based practice. After the intervention period the third assessment will take place at T2. Following the intervention, there will be a five-week no-intervention period for all participants. After this, a follow-up assessment will take place at T3.
| Arm | Type | Receives |
|---|---|---|
| Slow paced breathing (SPB) | Active comparator | Device: Guided breathing exercise - SPBThe participants will receive a 5-week training, starting with one visit to explain the procedure and determine the individual resonance frequency (for reasons of comparison). Afterwards, participants are instructed to practice at home, using the Pebbles. The breathing frequency of the Pebbles will be set at 6 breaths/minute (3-1-4-2) (slow-paced breathing) and participants are instructed to practice 4x5 minutes a day. In week 2 and week 3, follow-up sessions will be scheduled with each participant (in line with the protocol for the HRV-BF group). Similar to the HRV-BF group, the participants will be asked to rate the level of comfort during the training via a secure web-based application (m-path, KU Leuven) and compliance and physiological data will be captured with the Pebbles. The device used to support the home-based training. |
| Heart rate variability biofeedback (HRV-BF) | Active comparator | Device: Guided breathing exercise - HRV-BFThe participants will follow a fixed scheme: consisting of 3 supervised sessions (30 minutes) combined with home-practice on the other days (20 minutes, 4x5 minutes/day), followed by a training period of 2 weeks, without supervised sessions. In the first session, the personal resonance frequency of the participant will be determined. The resonance frequency refers to a breathing frequency between 4.5 and 7 breaths per minute at which heart rate and the breathing pattern are in phase, also known as Respiratory Sinus Arrhythmia. This introductory session is followed by two supervised training session in week 2 and 3. The participants will be asked to rate the level of comfort during the training via a secure web-based application (m-path, KU Leuven) and compliance and physiological data will be captured with the Pebbles. The device used to support the home-based training. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- For participants ≥18 years a voluntary written informed consent and for participants < 18 years a written informed consent from the parents or their legally authorized representative and an informed assent of the participant has been obtained prior to any screening procedures
- Male or Female (biological)
- Between 16 and 25 years old
- Diagnosis of autism as described in the DSM-IV/DSM-5(-TR)
Key exclusion criteria (8 listed)
- Participant has a history of congenital heart diseases, diagnosed cardiovascular abnormalities or somatic diseases conditions that may interfere with the main outcome measure HRV or with the safe practice of breathing exercises (e.g., uncontrolled epilepsy, severe respiratory illness)
- Presence of contra-indications for participating (intervention and/or assessment): acute agitation and/or severe psychiatric symptoms (psychosis, mania or major depression) and/or active substance use.
- The presence of an intellectual disability, defined as an intelligence quotient < 70, as described in the DSM-IV/DSM-V.
- Insufficient knowledge of Dutch language in order to follow instructions and fill out questionnaires.
- Female who is pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided breathing exercise - SPBGuided breathing exercises are performed at a fixed pace of 6 breaths per minute (SPB) . | Device | Slow paced breathing (SPB) |
| Guided breathing exercise - HRV-BFGuided breathing exercises are performed at each participant's individually determined resonance frequency, which typically falls between 4.5 and 7 breaths per minute (HRV-BF). | Device | Heart rate variability biofeedback (HRV-BF) |
Primary outcome
Change in cardiac vagal modulation of heart rate based on resting-state HRV.
Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Calculated as (1) a time domain measure (RMSSD: Root Mean Square of Successive Differences). Three-lead electrocardiographic data will be captured using the NeXus-10 MKII biofeedback device and Biotrace+ Software (MindMedia B.V., The Netherlands). Disposable, self-adhesive and pre-gelled electrodes (Kendall™ ECG Electrodes Arbo™ H124SG, Covidien, Ireland) will be used without specific skin preparations at a sampling rate of 256 SPS. For the recording of the breathing frequency, an elastic band with stretch-sensitive sensors and a sampling rate of 32 SPS is placed around the waist.
Change in cardiac vagal modulation of heart rate based on resting-state HRV
Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Calculated as (2) a frequency domain measures (HF-HRV). Three-lead electrocardiographic data will be captured using the NeXus-10 MKII biofeedback device and Biotrace+ Software (MindMedia B.V., The Netherlands). Disposable, self-adhesive and pre-gelled electrodes (Kendall™ ECG Electrodes Arbo™ H124SG, Covidien, Ireland) will be used without specific skin preparations at a sampling rate of 256 SPS. For the recording of the breathing frequency, an elastic band with stretch-sensitive sensors and a sampling rate of 32 SPS is placed around the waist.
10 secondary outcomes
Change in mental health indicators
Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Change in mental health indicators
Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
Change in mental health indicators
Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)
feasibility and acceptability of the HRV-BF and SPB interventions.
Time frame: For 5 weeks 4 times per day (before and after each sessions) during the intervention phase (between week 5 and week 10)
feasibility and acceptability of the HRV-BF and SPB interventions.
Time frame: For 5 weeks 4 times per day during the intervention phase (between week 5 and week 10)
feasibility and acceptability of the HRV-BF and SPB interventions.
Time frame: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.
feasibility and acceptability of the HRV-BF and SPB interventions.
Time frame: During the guided intervention sessions at week 5, 6 and 7.
feasibility and acceptability of the HRV-BF and SPB interventions.
Time frame: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.
feasibility and acceptability of the HRV-BF and SPB interventions.
Time frame: At time point 3 (week 15) during the follow-up assessment
Feasibility and acceptability of the HRV-BF and SPB interventions.
Time frame: At time point 3 (week 15) during the follow-up assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (demographics, primary and secondary outcome measures, adverse events) will be shared. No directly identifying information will be included. The interview questions will be shared, but interview responses will not be made available in order to protect participant privacy. The study protocol, the statistical analysis plan, analytic code, and a blank informed consent form will be shared. The de-identified dataset will be accompanied by clear documentation explaining the variables, coding, and outcome measures so that researchers can interpret the data without access to the full protocol or analysis plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tine Van Damme, Prof. dr. principal investigator
KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided breathing exercise - SPB and Guided breathing exercise - HRV-BF in people with Autism and Autism Spectrum Disorder, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther Meers (+32 479976950, esther.meers@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac vagal modulation of heart rate based on resting-state HRV. (time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.