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New treatment option for Autism
Official title Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism
ClinicalTrials.gov ID: NCT07238153
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 25
You may be able to join if
- For participants ≥18 years a voluntary written informed consent and for participants \< 18 years a written informed consent from the parents or their...
- Male or Female (biological)
- Between 16 and 25 years old
- Diagnosis of autism as described in the DSM-IV/DSM-5(-TR)
You likely can't join if
- Participant has a history of congenital heart diseases, diagnosed cardiovascular abnormalities or somatic diseases conditions that may interfere with...
- Presence of contra-indications for participating (intervention and/or assessment): acute agitation and/or severe psychiatric symptoms (psychosis...
- 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 treatment study, with or without an investigational medicinal product (IMP) or device (IMD).
See the full eligibility 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...
- Male or Female (biological)
- Between 16 and 25 years old
- Diagnosis of autism as described in the DSM-IV/DSM-5(-TR)
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams Brabant, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams Brabant, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.