An interventional study of Telepractice group voice therapy and Face-to-face group voice therapy in Voice Disorders, Muscle Tension Dysphonia and Aphonia, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare face-to-face group voice therapy to telepractice group voice therapy for muscle tension dysphonia (MTD). The main questions it aims to answer are:
Participants will receive telepractice group voice therapy or face-to-face group voice therapy. Researchers will compare telepractice group voice therapy to face-to-face group voice therapy for patients with MTD to see if it has the same effectiveness.
STUDY OBJECTIVES
Primary Objectives
Secondary Objectives
BACKGROUND
Muscle tension dysphonia
Types and prevalence Muscle tension dysphonia (MTD) is a type of voice disorder that is characterized by excessive paralaryngeal musculature tension during phonation. There are two types of MTD, primary and secondary. Primary MTD is associated with the absence of organic vocal fold pathology, whereas secondary MTD is associated with the presence of organic vocal fold pathology.
MTD is a prevalent voice disorder which constitutes up to 40% of the total voice disorder caseload. In Hong Kong, a study by our team also showed that MTD was highly prevalent in every four primary school teachers, one would have some degree of MTD.
MTD not only disrupts a person's voice quality but also their efficiency to produce voice for communication leading to impaired psychological wellbeing, reduced job performance, and economic loss due to workplace absenteeism.
Voice therapy is the treatment for MTD
The current gold standard treatment for primary MTD is behavioural voice therapy delivered by speech-language pathologists. For secondary MTD, behavioural voice therapy is recommended for those with vocal fold nodules. However, for other benign vocal fold pathologies, such as vocal polyps, cysts and granuloma, may require phonosurgery as their primary treatment modality.
Delivering voice therapy via telepractice
In addition to the individual and group model of service delivery, voice therapy has also been extended into telepractice. Our team was among the first to introduce and provide preliminary evidence to support the use of telepractice in voice therapy for patients with MTD.
The reason for telepractice voice therapy Telepractice was initially applied to voice therapy with the aim to reduce service access barriers due to traveling requirements, work commitments and access to experienced clinicians and patient mobility. However, due to the arrival of COVID-19 pandemic, social distancing policies and lockdowns have caused an abrupt disruption of all in-person voice therapy programs.
This has left thousands of patients worldwide without any treatment and hence has prolonged and aggravated the negative impact on their professional careers and emotional well-being. Even for those who can attend in-person voice therapy, they are likely to be required to wear masks to mitigate COVID-19 transmission risk. It is important to understand that mask wearing can affect a person's voice quality and production. As such, the treatment effect would unavoidably be impacted.
Following the preliminary studies on telepractice voice therapy published in 2015, only two additional studies were found in the literature on telepractice voice therapy. Although both studies showed that the effectiveness of telepractice voice therapy is comparable to face-to-face therapy, they were provided on an individual basis and on different clinical populations. One study focused on the elderly population with various types of voice disorders and the other study focused on voice prevention for those who are at risk at developing voice disorder.
To date, there are no high-quality clinical trials investigating the effectiveness of telepractice voice therapy for patients with MTD, especially when delivered in a group model.
77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.
This study's planned enrollment of 168 is above the median of 41 across 54 interventional studies indexed under Voice Disorders.
Browse Voice Disorders studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Voice therapy delivered in group basis via telepractice.
Behavioral: Telepractice group voice therapy
Voice therapy that will be delivered in group basis in-person with patients.
Behavioral: Face-to-face group voice therapy
* Voice therapy delivered in group basis via telepractice. * The voice therapy program will include both indirect and direct voice therapy, in accordance with the current best practice recommendations. Indirect voice therapy will include information counselling on voice production and disorder and vocal hygiene. Direct voice therapy will adopt the resonant voice therapy approach and also head and neck relaxation exercises, which has shown to be effective for muscle tension dysphonia.
* Voice therapy that will be delivered in group basis in-person with patients. * The voice therapy program will include both indirect and direct voice therapy, in accordance with the current best practice recommendations. Indirect voice therapy will include information counselling on voice production and disorder and vocal hygiene. Direct voice therapy will adopt the resonant voice therapy approach and also head and neck relaxation exercises, which has shown to be effective for muscle tension dysphonia.
Change in patient-related outcome measure
The Chinese Voice-Handicap Index (VHI-30) is a reliable patient-related outcome measure. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. VHI-30 has 30 items. Each item is rated on a scale from with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always. Statistical analysis: Two-way repeated measures of ANOVA to compare between group performance. To allow for non-inferiority analysis, the 95% confidence interval of the difference in VHI scores between the two groups will be calculated. The upper limit of the 95% CI will be used to determine whether the difference between group is within the non-inferiority margin.
Time frame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Change in laryngeal imaging
Videostroboscopy will be conducted to identify anatomical and physiological outcomes. These include presence of laryngeal pathology, laryngeal physiological patterns. Two experienced laryngologists blinded to the patient's information will rate the video recordings. Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
Time frame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Change in perceptual evaluation of voice
Patients' voice quality will be assessed using the Cantonese Perceptual Evaluation of Voice scale (Thomas Law, Lee, Lam, van Hasselt, \& Tong, 2013). Two experienced speech-language pathologists blinded to the patient's information will rate the audio recordings. Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
Time frame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Change in acoustic voice analysis
The Computerized Speech Lab system will be used to measure parameters including jitter, shimmer, and noise-to-harmonic ratio and cepstral peak prominence. Statistical analysis: Acoustic analysis will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
Time frame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Change in aerodynamic measures
Maximum phonation time will be measured. Statistical analysis: Aerodynamic measure will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
Time frame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Therapy dropout rate and treatment schedule adherence rate
This will be measured by comparing the proportion of patient dropout and non-adherence to treatment schedule in both modes of treatment. Statistical analysis will be conducted using the Z-test.
Time frame: Immediately after the intervention
Cost analysis
This will follow the cost analysis approach suggested by Burns and colleagues. Cost domains including human resource cost, patient cost and equipment cost. Statistical analysis will be conducted using the t-test.
Time frame: Immediately after the intervention
Group climate
The group climate questionnaire will be used to measure the therapeutic relationship at the final session of each therapy group. Statistical analysis: the contribution of group climate to treatment outcome will be measured using correlation analysis and one-way repeated ANOVA.
Time frame: Immediately after the intervention
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for May 2026, 23 months after the start.
Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese University of Hong Kong →