NCT07238153 Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism
| NCT ID | NCT07238153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-11-30 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2025-11-30 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Additionally, the study investigates how participants perceive the exercises in terms of usability and usefulness.
Eligibility 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.
Contact & Investigator
Tine Van Damme, Prof. dr.
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT07238153 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 25 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07238153 currently recruiting?
Yes, NCT07238153 is actively recruiting participants. Contact the research team at esther.meers@kuleuven.be for enrollment information.
Where is the NCT07238153 trial being conducted?
This trial is being conducted at Leuven, Belgium, Leuven, Belgium.
Who is sponsoring the NCT07238153 clinical trial?
NCT07238153 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Tine Van Damme, Prof. dr. at KU Leuven. The trial plans to enroll 68 participants.