[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523814":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":75,"collaborators":77,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":36,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":36,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":56,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University Ghent","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Autonomic nervous system (ANS) regulation therapy","EXPERIMENTAL","HRV biofeedback is a non-invasive intervention that focuses on increasing heart rate oscillations through real-time feedback and slow-paced breathing training (Lehrer et al., 2020; Laborde et al., 2022; Pizzoli et al., 2021). Participants will practice 20 min a day (2 sessions of 10 min) for 1 month. One weekly session will be organized in the clinic under the guidance of the therapist (individual sessions), the other sessions will be organized at home, and tracked by a chest strap heart rate monitor (Polar H10) and the Elite HRV app (elitehrv.com). First, the resonance frequency (RF) (i.e. respiration rate with the highest HRV) will be personalized for each participant. Biofeedback slow-paced breathing exercises in the app will then be customized based on this RF (40% inhale, 60% exhale: e.g. 6 bpm: 4s inhale, 6s exhale). Participants will be asked to breathe in through the nose and breathe out through pursed lips, following the breath pacer with visual feedback.",[13],"Behavioral: ANS regulation therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"conventional voice therapy (CVT)","ACTIVE_COMPARATOR","The CVT will be based on Meerschman et al. (2019). This therapeutic program has been proven effective in voice therapy and is the standard clinical care for FD patients. The program is a combination of education, vocal hygiene, posture, local relaxation, costo-abdominal breathing, resonant voice, voice placing, forward focus, voice onset, semi-occluded vocal tract exercises and laryngeal manipulation. Identical to the ANS regulation therapy, participants will practice 20 min a day for 1 month. One weekly session will be organized in the clinic under the guidance of the therapist (individual sessions), the other sessions will be organized at home and tracked by the RedCap app.",[19],"Behavioral: conventional voice therapy (CVT)",{"label":21,"type":16,"description":22,"interventionNames":23},"ANS regulation therapy + CVT","The third group will receive a combination of both therapies. The same frequency and duration of practice (20 min a day for 1 month) will apply. They will also receive one weekly session in the clinic under the guidance of the therapist (individual sessions) and the other sessions will be completed at home, tracked by the Elite HRV app and the RedCap app.",[24],"Behavioral: ANS regulation therapy + CVT",[26,33,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","ANS regulation therapy","innovative intervention for functional dysphonia",[9],[32],"HRV biofeedback",{"type":27,"name":15,"description":34,"armGroupLabels":35,"otherNames":36},"conventional voice therapy traditionally provided for functional dysphonia",[15],null,{"type":27,"name":21,"description":38,"armGroupLabels":39,"otherNames":36},"combination of ANS regulation therapy and CVT",[21],[41],{"name":42,"affiliation":5,"role":43},"Kristiane Van Lierde, PhD","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":36,"email":49},"Iris Meerschman, PhD","CONTACT","+32499294636","iris.meerschman@ugent.be",{"name":51,"role":47,"phone":36,"phoneExt":36,"email":52},"Evelien D'haeseleer, PhD","evelien.dhaeseleer@ugent.be",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Department of Rehabilitation Sciences, Ghent University (Hospital)","RECRUITING","Ghent","East-Flanders","9000","Belgium","BE",{"type":63,"coordinates":64},"Point",[65,66],3.71667,51.05,{"lat":66,"lon":65},[69,70,72,74],{"name":46,"role":47,"phone":48,"phoneExt":36,"email":49},{"name":42,"role":47,"phone":36,"phoneExt":36,"email":71},"kristiane.vanlierde@ugent.be",{"name":51,"role":73,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"name":42,"role":43,"phone":36,"phoneExt":36,"email":36},{"type":76,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[78,80],{"name":79,"class":6},"Universiteit Antwerpen",{"name":81,"class":6},"University of Utah","100523814","autonomic-dysfunction-in-functional-dysphonia-100523814",false,"NCT06100601","Autonomic Dysfunction in Functional Dysphonia","Patients with functional dysphonia will be recruited from a treatment-seeking population consulting at the voice clinic of Ghent University Hospital. Inclusion criteria are all genders, all ethnicities, aged 18 - 60 years (to exclude voice-related changes due to puberty\u002Fmutation or aging\u002Fpresbyphonia), diagnosed with FD by an experienced otorhinolaryngologist and SLP (defined by a voice disorder in the absence of organic or structural mucosal disease and\u002For neuropathology sufficient to explain the voice disturbance (Roy et al., 2003), as determined with strobovideolaryngoscopy and a multidimensional voice assessment). Exclusion criteria include: being diagnosed with an organic voice disorder, current participation in voice therapy, practice of breathing exercises including mediation and yoga, current participation in psychotherapy or physical rehabilitation, pharmacological treatment (i.e. antidepressants, antipsychotics, heart medication, antihypertensives, inhalers), previous phonosurgical interventions, lung diseases, endocrinologic diseases, metabolic diseases, cardiovascular diseases, neurologic diseases, nasal or ear diseases, pregnancy, asthma, smoking or drug consumption.\n\nFor the vocally healthy controls, inclusion criteria are all genders, all ethnicities, aged 18 - 60 years, and matched with the FD groups by age and gender. The same exclusion criteria as above apply, with the addition of: 'diagnosed with FD'.",true,"ALL","18 Years","60 Years",{"count":93,"type":94},100,"ESTIMATED","INTERVENTIONAL",[97],"NA","The first objective of this research project is to compare the occurrence and frequency of symptoms and\u002For disorders related to autonomic dysfunction in patients with functional dysphonia with gender- and age-matched vocally healthy controls, using a case-control study.\n\nThe second objective is to compare the effects of a novel therapy based on autonomic nervous system regulation (i.e., ANS therapy: heart rate variability biofeedback), for functional dysphonia versus coventional voice therapy (CVT) alone or in combination with ANS regulation therapy (i.e., ANS therapy + CVT), using a longitudinal randomized controlled trial (RCT).",[100,101,102],"Functional Voice Disorder","Psychogenic Voice Disorder","Muscle Tension Dysphonia",[104],"Autonomic nervous system, functional dysphonia, heart rate variability, psychophysiology","2023-10-20",{"date":107,"type":108},"2023-10-25","ACTUAL",{"date":110,"type":108},"2023-10-10",{"date":112,"type":94},"2026-12",{"name":5,"class":6},1]