RecruitingNot ApplicableNCT07238153

Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

68 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 25 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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.

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Interventions

DEVICEGuided breathing exercise - SPB

Guided breathing exercises are performed at a fixed pace of 6 breaths per minute (SPB) .

DEVICEGuided breathing exercise - HRV-BF

Guided breathing exercises are performed at each participant's individually determined resonance frequency, which typically falls between 4.5 and 7 breaths per minute (HRV-BF).


Locations(2)

KU Leuven

Leuven, Vlaams Brabant, Belgium

UPC Z.Org

Leuven, Belgium

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NCT07238153


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