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

NCT ID: NCT07238153

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-04-01

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.

Detailed Description

For many autistic individuals, transitioning into adulthood can be challenging and stressful. This stress often affects their mental health. The autistic community has highlighted the need for better mental health support, including accessible and effective ways to manage stress. Among the non-pharmacological interventions aimed at improving mental health via stress reduction, guided breathing interventions are promising, also on a psychophysiological level. During a stressful situation, internal regulatory processes take place to maintain balance, starting by activating the autonomic nervous system (ANS). Prior work indicates that a dysfunction of the ANS contributes to the heightened mental health challenges observed in autistic individuals. Heart rate variability (HRV), the variation in time between heartbeats, is an physiological index of the functioning of the ANS. The Neurovisceral Integration Theory highlights the role of parasympathetic regulation of the heart rate, associating higher vagally mediated HRV with better health, emotional regulation and executive functioning.In autistic individuals, the overall levels of cardiac vagal modulation are lower compared to neurotypical peers.

To date, research investigating the potential of interventions aimed at increasing HRV in autistic individuals is scarce. Moreover, HRV is influenced by several aspects (e.g., sleep, physical activity) and knowledge on their combined impact is necessary to understand how HRV can be used in research and clinical practice. Therefore, in this project, the investigators will explore the role of physical activity, sedentary behavior, and sleep on HRV and determine what constitutes a significant change in HRV.

The investigators will also examine the psychophysiological effects, feasibility, and acceptability of the two leading protocols in guided breathing interventions (heart rate variability biofeedback and slow-paced breathing). HRV-BF optimizes HRV by guiding individuals to breathe at their resonance frequency, synchronizing heart rate and breathing. SPB prescribes to breathe at a fixed pace of 6 breaths per minute.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slow paced breathing (SPB)

The participants will receive a 5-week training, starting with one visit to explain the procedure and determine the individual resonance frequency (for reasons of comparison). Afterwards, participants are instructed to practice at home, using the Pebbles. The breathing frequency of the Pebbles will be set at 6 breaths/minute (3-1-4-2) (slow-paced breathing) and participants are instructed to practice 4x5 minutes a day. In week 2 and week 3, follow-up sessions will be scheduled with each participant (in line with the protocol for the HRV-BF group). Similar to the HRV-BF group, the participants will be asked to rate the level of comfort during the training via a secure web-based application (m-path, KU Leuven) and compliance and physiological data will be captured with the Pebbles. The device used to support the home-based training.

Group Type: ACTIVE_COMPARATOR

Guided breathing exercise - SPB

Intervention Type: DEVICE

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

Heart rate variability biofeedback (HRV-BF)

The participants will follow a fixed scheme: consisting of 3 supervised sessions (30 minutes) combined with home-practice on the other days (20 minutes, 4x5 minutes/day), followed by a training period of 2 weeks, without supervised sessions. In the first session, the personal resonance frequency of the participant will be determined. The resonance frequency refers to a breathing frequency between 4.5 and 7 breaths per minute at which heart rate and the breathing pattern are in phase, also known as Respiratory Sinus Arrhythmia. This introductory session is followed by two supervised training session in week 2 and 3. The participants will be asked to rate the level of comfort during the training via a secure web-based application (m-path, KU Leuven) and compliance and physiological data will be captured with the Pebbles. The device used to support the home-based training.

Group Type: ACTIVE_COMPARATOR

Guided breathing exercise - HRV-BF

Intervention Type: DEVICE

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).

Interventions

Guided breathing exercise - SPB

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

Intervention Type: DEVICE

Guided 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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tine Van Damme, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven

Leuven, Vlaams Brabant, Belgium

UPC Z.Org

Leuven, , Belgium

Countries

Belgium

Central Contacts

Esther Meers

Role: CONTACT

esther.meers@kuleuven.be

+32 479976950

Facility Contacts

Esther Meers

Role: primary

esther.meers@kuleuven.be

+323 479976850

Esther Meers

Role: primary

esther.meers@kuleuven.be

+32 479976850

Tine Van Damme, Prof. dr.

Role: backup

tine.vandamme@kuleuven.be

Other Identifiers

S70725

Identifier Type: -

Identifier Source: org_study_id