Publication Date: November 28, 2025
A groundbreaking clinical trial is set to explore the efficacy of guided breathing exercises using medical devices for emotional and autonomic regulation in emerging adults with autism spectrum disorder (ASD). Sponsored by Universitaire Ziekenhuizen KU Leuven, this trial introduces two device-based interventions: the SPB-guided breathing exercise and HRV-BF-guided breathing exercise. Though the study has not yet begun recruiting participants, its potential impacts on therapy for ASD warrant close attention from clinical professionals.
What changed?
This upcoming clinical trial represents an advancement in non-invasive interventions for autism spectrum disorder. It focuses specifically on guided breathing exercises, leveraging medical devices that target emotional stability and autonomic control. Experts in clinical therapy and device regulation should anticipate innovative findings that could reshape therapeutic approaches for emerging adults with ASD.
Clinical trial overview
The study acknowledges the challenges faced by emerging adults with ASD, particularly with managing autonomic and emotional responses. Universitaire Ziekenhuizen KU Leuven has taken the lead in investigating device-powered solutions. The two primary interventions include:
- SPB-guided breathing exercise: A structured breathing protocol designed for emotional regulation.
- HRV-BF-guided breathing exercise: A heart rate variability biofeedback device intended to enhance autonomic stability.
As noted in the ClinicalTrials.gov listing, recruitment for the study has not yet commenced. Researchers and professionals monitoring innovations in ASD treatment should stay informed about updates.
How do the devices work?
The SPB and HRV-BF devices provide targeted support by leveraging physiological feedback mechanisms:
SPB-guided breathing exercise
This intervention focuses on slow-paced breathing techniques tailored to reduce emotional dysregulation. Built into its design are evidence-based protocols that synchronize breathing patterns with emotional calming mechanisms.
HRV-BF-guided breathing exercise
The HRV-BF device uses heart rate variability as a measurable input to inform breathing exercises. By monitoring autonomic shifts through HRV metrics, it optimizes breathing feedback to improve regulation.
Both devices align with regulatory expectations for performance and safety in medical devices dedicated to therapeutic use.
FAQ
1. Who is eligible for the study?
Emerging adults diagnosed with autism spectrum disorder are the population focus. Further eligibility criteria will be established during recruitment.
2. Are the devices commercially available?
No, the SPB and HRV-BF devices are investigational and utilized exclusively within the context of this clinical trial.
3. What regulatory standards apply?
Medical devices involved in clinical trials must comply with performance and safety standards outlined in MDR Annex XIV.
Conclusion
This upcoming clinical trial introduces a promising approach to addressing emotional and autonomic challenges in emerging adults with ASD. Leveraging medical devices like SPB and HRV-BF, researchers aim to gather evidence that may transform therapeutic practices in autism care. Professionals should monitor the trial’s progress for potential regulatory approval and broader application in clinical settings.
Disclaimer
This article provides information targeting clinical, quality, and regulatory audiences. It is not legal advice and should not replace guidance from regulatory authorities or compliance teams.
Announcement and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07238153?term=medical+device