评估呼吸窦性心律失常生物反馈对减少自闭症青少年生理应激的潜力：一项随机对照试验的研究方案。
Evaluating the potential of respiratory-sinus-arrhythmia biofeedback for reducing physiological stress in adolescents with autism: study protocol for a randomized controlled trial.
机构信息
Department of Rehabilitation Sciences, Research Group for Adapted Physical Activity and Psychomotor Rehabilitation, KU Leuven, Leuven, Belgium.
Leuven Autism Research (LAuRes), KU Leuven, Leuven, Belgium.
出版信息
Trials. 2021 Oct 21;22(1):730. doi: 10.1186/s13063-021-05709-4.
BACKGROUND
Prior evidence points towards lower cardiac vagal modulation in individuals with autism spectrum disorder (ASD) as compared to control groups. A cross-sectional phase in this study will gather more evidence concerning this topic. A longitudinal phase will explore the efficacy of a biofeedback intervention based on respiratory sinus arrhythmia (RSA) in adolescents with ASD. Finally, a feasibility study will focus on a non-supervised RSA biofeedback intervention in this population.
METHODS
The cross-sectional phase includes the comparison of adolescents with ASD (n=38) and age- and gender-matched typically developing peers. A standardized assessment will be used which contains physiological, cortisol, and behavioral measurements. The longitudinal phase contains a randomized, single-blinded, and sham-controlled design to determine the efficacy of supervised RSA biofeedback in adolescents with ASD (n=128). A follow-up phase of 5 weeks is included to evaluate the presence of retention effects. During the latter, a feasibility study will focus on a non-supervised intervention (n=64). Assessments as described previously are scheduled after the intervention and the follow-up phase.
DISCUSSION
First, more conclusive evidence will be provided for the presence of lower cardiac vagal modulation in adolescents with ASD as well as the association between these lower values and physiological and behavioral indices. Second, the supervised intervention in adolescents with ASD is hypothesized to upregulate this cardiac vagal modulation and positively change behavioral and physiological parameters. Third, evidence regarding the feasibility and acceptability of a non-supervised intervention may open novel avenues for home-based interventions in this population.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04628715 . Registered on 13 November 2020.
背景
先前的证据表明，与对照组相比，自闭症谱系障碍（ASD）个体的心脏迷走神经调节较低。本研究的横断面阶段将收集更多关于这一主题的证据。纵向阶段将探索基于呼吸窦性心律失常（RSA）的生物反馈干预对 ASD 青少年的疗效。最后，一项可行性研究将专注于该人群的非监督 RSA 生物反馈干预。
方法
横断面阶段包括比较 ASD 青少年（n=38）和年龄、性别匹配的正常发育同龄人。将使用标准化评估，其中包含生理、皮质醇和行为测量。纵向阶段包含随机、单盲和假对照设计，以确定监督 RSA 生物反馈对 ASD 青少年（n=128）的疗效。包括 5 周的随访阶段，以评估保留效果。在后者中，将重点关注非监督干预（n=64）的可行性研究。干预和随访阶段后安排了之前描述的评估。
讨论
首先，将为 ASD 青少年心脏迷走神经调节较低以及这些较低值与生理和行为指标之间的关联提供更具结论性的证据。其次，假设对 ASD 青少年进行监督干预可以上调这种心脏迷走神经调节，并积极改变行为和生理参数。第三，关于非监督干预的可行性和可接受性的证据可能为该人群的家庭为基础的干预开辟新途径。
试验注册
ClinicalTrials.gov NCT04628715 。2020 年 11 月 13 日注册。
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