Guided breathing to improve stress and heart rate variability in autistic young adults
Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism
This study will test two guided breathing exercises to see if they reduce stress and improve heart rate variability in autistic people aged 16–25.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 16 Years to 25 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 2 sites (Leuven, Vlaams Brabant and 1 other locations) |
| Trial ID | NCT07238153 on ClinicalTrials.gov |
What this trial studies
Participants aged 16–25 with an autism diagnosis will practice two types of guided breathing (slow-paced breathing and HRV biofeedback) while researchers record heart rate variability and stress-related measures. Daily movement behaviour—sleep, physical activity, and sedentary time—will be tracked to understand how these behaviours influence HRV. The study pairs physiological monitoring with questionnaires about the usability and perceived usefulness of the exercises. People with significant cardiovascular, respiratory, intellectual, or severe psychiatric conditions are excluded and sessions take place at KU Leuven/UPC Z.Org in Leuven, Belgium.
Who should consider this trial
Good fit: Autistic individuals aged 16–25 who can provide consent (or whose guardians can consent), and who do not have intellectual disability or serious uncontrolled cardiac, respiratory, or psychiatric conditions, are the intended participants.
Not a fit: People with congenital heart disease, severe respiratory illness, uncontrolled epilepsy, active severe psychiatric symptoms, intellectual disability, or those outside the 16–25 age range are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, these breathing exercises could offer an accessible, low-cost way for autistic young adults to manage stress and improve autonomic regulation.
How similar studies have performed: Breathing techniques and HRV biofeedback have shown benefits for stress and autonomic regulation in other populations, but strong evidence specifically in autistic young adults is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Where this trial is running
Leuven, Vlaams Brabant and 1 other locations
- KU Leuven — Leuven, Vlaams Brabant, Belgium (Recruiting)
- UPC Z.Org — Leuven, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Tine Van Damme, Prof. dr. — KU Leuven
- Study coordinator: Esther Meers
- Email: esther.meers@kuleuven.be
- Phone: +32 479976950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.