Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults … (NCT07238153) | Clinical Trial Compass
RecruitingNot Applicable
Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism
Belgium68 participantsStarted 2025-11-30
Plain-language 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.
Who can participate
Age range
16 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cardiac vagal modulation of heart rate based on resting-state HRV.
Timeframe: 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)
2
Change in cardiac vagal modulation of heart rate based on resting-state HRV
Timeframe: 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)