Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100601
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-20
Brief Title:
Autonomic Dysfunction in Functional Dysphonia
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
Autonomic Dysfunction in Functional Dysphonia
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The first objective of this research project is to compare the occurrence and frequency of symptoms andor disorders related to autonomic dysfunction in patients with functional dysphonia with gender- and age-matched vocally healthy controls using a case-control study
The second objective is to compare the effects of a novel therapy based on autonomic nervous system regulation ie ANS therapy heart rate variability biofeedback for functional dysphonia versus coventional voice therapy CVT alone or in combination with ANS regulation therapy ie ANS therapy CVT using a longitudinal randomized controlled trial RCT
The second objective is to compare the effects of a novel therapy based on autonomic nervous system regulation ie ANS therapy heart rate variability biofeedback for functional dysphonia versus coventional voice therapy CVT alone or in combination with ANS regulation therapy ie ANS therapy CVT using a longitudinal randomized controlled trial RCT
Detailed Description:
Background Although psychological factors have been implicated in patients with functional dysphonia FD conventional treatment typically targets the aberrant voice symptoms exclusively Yet symptomaticconventional voice therapy CVT is not always successful and in view of the significant adverse quality of life QoL impact combined with the substantial financial burden on the healthcare system and society research is needed to elucidate the underlying pathogenesis and psychophysiology of FD and improve treatment outcomes Given that 1 the Vagus nerve not only innervates the larynx but helps to regulate the autonomic nervous system ANS 2 autonomic dysfunction is well recognized in the fields of psychology and psychiatry but remains relatively understudied in the area of voice disorders and 3 many of the psychological symptomsfeatures commonly observed in patients with FD may reflect ANS dysregulation we intend to investigate ANS dysfunction as a potential psychophysiological mechanism underlying FD and to evaluate the comparative effectiveness of a novel therapy that aims to improve ANS regulation in patients with FD
Objectives The first objective of this research project is to compare the occurrence and frequency of symptoms andor disorders related to autonomic dysfunction in patients with FD with gender- and age-matched vocally healthy controls using a case-control study The second objective is to compare the effects of a novel therapy based on ANS regulation ie ANS therapy heart rate variability biofeedback for FD versus CVT alone or in combination with ANS regulation therapy ie ANS therapy CVT using a longitudinal randomized controlled trial RCT
Methods Case-control study Autonomic dysfunction of patients with FD will be compared with gender- and age-matched vocally healthy controls using both physiological measures eg heart rate variability skin conductance level and psychological patient-reported outcome measures PROMs eg Neuroception of Psychological Safety Scale Depression Anxiety and Stress Scale RCT The FD group will be randomly assigned to the innovative ANS therapy group the CVT group or the ANS therapy CVT group All patients will receive 1 month of treatment with 20min of daily practice Both the autonomic assessment and the voice assessment will be performed pretherapy immediately after therapy and at 3 months follow-up by assessors blinded to group allocation and study phase
Expected results Higher occurrence of symptoms andor disorders related to autonomic dysfunction are expected in patients with FD compared with vocally healthy controls Physiological outcomes Lower heart rate variability lower cardiac pre-ejection period higher respiration rate and higher skin conductance level are hypothesized in patients with FD compared with vocally healthy controls Psychological PROMs Higher self-report of feelingssymptoms related to autonomic dysfunction eg perceived stress anxiety is expected in patients with FD compared with vocally healthy controls Autonomic function is hypothesized to improve more after the ANS therapy and the ANS therapy CVT compared with the CVT only Voice function is expected to improve more after the ANS therapy CVT compared with the ANS therapy and the CVT alone
Objectives The first objective of this research project is to compare the occurrence and frequency of symptoms andor disorders related to autonomic dysfunction in patients with FD with gender- and age-matched vocally healthy controls using a case-control study The second objective is to compare the effects of a novel therapy based on ANS regulation ie ANS therapy heart rate variability biofeedback for FD versus CVT alone or in combination with ANS regulation therapy ie ANS therapy CVT using a longitudinal randomized controlled trial RCT
Methods Case-control study Autonomic dysfunction of patients with FD will be compared with gender- and age-matched vocally healthy controls using both physiological measures eg heart rate variability skin conductance level and psychological patient-reported outcome measures PROMs eg Neuroception of Psychological Safety Scale Depression Anxiety and Stress Scale RCT The FD group will be randomly assigned to the innovative ANS therapy group the CVT group or the ANS therapy CVT group All patients will receive 1 month of treatment with 20min of daily practice Both the autonomic assessment and the voice assessment will be performed pretherapy immediately after therapy and at 3 months follow-up by assessors blinded to group allocation and study phase
Expected results Higher occurrence of symptoms andor disorders related to autonomic dysfunction are expected in patients with FD compared with vocally healthy controls Physiological outcomes Lower heart rate variability lower cardiac pre-ejection period higher respiration rate and higher skin conductance level are hypothesized in patients with FD compared with vocally healthy controls Psychological PROMs Higher self-report of feelingssymptoms related to autonomic dysfunction eg perceived stress anxiety is expected in patients with FD compared with vocally healthy controls Autonomic function is hypothesized to improve more after the ANS therapy and the ANS therapy CVT compared with the CVT only Voice function is expected to improve more after the ANS therapy CVT compared with the ANS therapy and the CVT alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None