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NOT YET RECRUITING
NCT07812233
PHASE2

Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

Heart rate variability biofeedback (HRVB) is a breathing-based intervention that reduces anxiety in a range of populations. Second-generation wearable HRVB devices not only deliver scheduled biofeedback practice sessions but also allow patients to practice HRVB in-the-moment when it is needed most. This study is testing the acceptability, feasibility, and preliminary efficacy of second-generation, ambulatory HRVB for the treatment of anxiety in autistic youth.

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-10-01

Completion Date

2029-05

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DEVICE

Lief Smart Patch

The Lief Smart Patch is a commercially available, noninvasive wearable heart rate variability biofeedback (HRVB) device. The patch includes an embedded electrocardiogram (ECG) sensor and accelerometer that interfaces with a companion smartphone application to deliver paced breathing exercises and just-in-time adaptive intervention (JITAI) prompts. It is an externally worn patch that temporarily adheres to the skin surface and can be removed by the participant.