Exploring autonomic dysfunction in functional dysphonia: A protocol for a case-control study and a randomized controlled trial.

What is already known on the subject Autonomic dysfunction is well recognized in the field of psychology but remains understudied in the area of voice. Given that the vagus nerve, innervating the larynx, also helps to regulate the ANS, and psychological symptoms commonly observed in patients with FD may reflect ANS dysregulation, research in this area is needed. There is some preliminary evidence that autonomic dysfunction might indeed be associated with FD. However, physiological ANS measures are needed, as well as validated psychological PROMs. What this paper adds to the existing knowledge The first objective of this study is to investigate the occurrence and frequency of symptoms and/or disorders related to autonomic dysfunction in patients with FD as compared with a gender- and age-matched vocally healthy control group. Autonomic (dys)function will be determined by employing both physiological measures (e.g., HRV, skin conductance level) and psychological PROMs (e.g., Neuroception of Psychological Safety Scale, Depression Anxiety and Stress Scale). The second objective is to compare the effects of a novel therapy for FD based on ANS regulation (HRV biofeedback) versus CVT alone or in combination with ANS therapy. What are the potential or actual clinical implications of this work? Success rates of symptomatic CVT for FD are highly variable. This study is expected to lead to innovative results related to the pathogenesis and psychophysiology of FD, a prevalent voice disorder associated with a significant adverse quality of life impact and a substantial financial burden on the healthcare system and society. The results of this study will lead to crucial new insights into both the diagnosis and treatment of FD, contributing to evidence-based practice in the field of voice.