Guided breathing to improve stress and heart rate variability in autistic young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.