Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

Study Overview
=================
Brief Summary
-----------------
A feasibility study to identify the immediate effect on the voices of patients with voice disorders (muscle tension dysphonia, vocal fold palsy or presbylaryngis) produced by exercising with Acapella Choice as a form of semioccluded vocal tract exercise (SOVTE).

Detailed Description
-----------------
This feasibility study is the natural extension of the researchers' recently completed study (R&D 16/0242) which assessed how the use of an Acapella Choice (Smiths Medical) positive expiratory pressure (PEP) device as a semi-occluded vocal tract exercise (SOVTE) impacted acoustic, electroglottographic and aerodynamic measures of the voice in a group of normophonic volunteers. In that study, Acapella Choice was found to offer significantly greater oscillating intraoral pressures than techniques in current clinical practice and was found to have measurable benefits in terms of producing a louder and more economical voice. It offered the largest oscillating pressures, likened to a 'massage' of the vocal organs, giving it great therapeutic promise for patients with excess vocal tract tension. This study seeks to evaluate the immediate effects of Acapella Choice as a voice exercise in patients with Muscle Tension Dysphonia, Presbylaryngis and Vocal Fold Palsy, and compare this to the widely-used voice rehabilitation technique of phonation into a tube held under water (henceforward referred to as Tube). Patients will be recruited from four weekly Voice Clinics held at the Royal National Throat Nose and Ear Hospital where their diagnosis will be confirmed. They will be invited to attend a single experimental session during which time they will exercise both with Acapella Choice and with Tube. Baseline and outcome voice measures will be taken and a short questionnaire will be completed, eliciting perceptions of the two exercises and any changes which were felt to have resulted from them. The researchers' previous work suggests that Acapella Choice as a SOVTE may offer significant clinical benefits in terms of improved efficacy of therapy. It is suggested that it also offers patients a more convenient and user-friendly form of exercise which may well improve compliance and result in better outcomes.

Official Title
-----------------
Evaluating the Therapeutic Use of a Vibratory Positive Expiratory Pressure Device (Acapella® Choice) in the Treatment of Pathological Voice - A Feasibility Study

Conditions
-----------------
Muscle Tension Dysphonia, Vocal Fold Palsy, Vocal Cord Paralysis, Presbylarynx, Dysphonia

Intervention / Treatment
-----------------
* Device: Acapella Choice
* Device: Tube-in-water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand written English without the need for an interpreter, No diagnosed communication impairment Endoscopically confirmed primary ENT diagnosis of either: muscle tension dysphonia (with no laryngeal abnormality), Vocal fold palsy Presbylaryngis. Exclusion Criteria: Previous SLT input Any of the following possible contraindications for PEP therapy: Inability to tolerate increased work of breathing, ICP (intracranial pressure) > 20mm Hg, Recent facial/oral/skull surgery or trauma, Oesophageal surgery, Untreated pneumothorax, Known or suspected tympanic membrane rupture/other middle ear pathology, Haemodynamic instability, Acute sinusitis, Epistaxis, Active haemoptysis, Nausea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a feasibility study using a 'before and after' design to test the immediate effects of exercising with Acapella Choice in comparison to the immediate effects of exercising with Tube-in-water resistance exercises (current treatment norm). Participants will be assigned groups according to their diagnosis (i.e. muscle tension group, vocal fold palsy group and presbylaryngis group). All participants will exercise with both techniques (i.e. Acapella and tube-in-water).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle Tension Group<br>10 participants with a diagnosis of muscle tension dysphonia will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions: Three minutes of semi-occluded vocal tract exercise with both Acapella Choice Three minutes of tube-in-water semi-occluded vocal tract exercise. Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes. Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention. Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy. | Device: Acapella Choice<br>* 3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.<br>* Other names: Semioccluded vocal tract exercise;Device: Tube-in-water<br>* 3 minutes of exercise consisting of blowing through a silicone tube (10mm internal diameter) submerged in 5 cm of water whilst phonating at the same time.<br>* Other names: Semi-occluded vocal tract exercise;|
| Experimental: Vocal Fold Palsy Group<br>10 participants with a diagnosis of (unilateral) vocal fold palsy will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions: Three minutes of semi-occluded vocal tract exercise with both Acapella Choice Three minutes of tube-in-water semi-occluded vocal tract exercise. Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes. Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention. Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy. | Device: Acapella Choice<br>* 3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.<br>* Other names: Semioccluded vocal tract exercise;Device: Tube-in-water<br>* 3 minutes of exercise consisting of blowing through a silicone tube (10mm internal diameter) submerged in 5 cm of water whilst phonating at the same time.<br>* Other names: Semi-occluded vocal tract exercise;|
| Experimental: Presbylaryngis Group<br>10 participants with a diagnosis of presbylaryngis will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions: Three minutes of semi-occluded vocal tract exercise with both Acapella Choice Three minutes of tube-in-water semi-occluded vocal tract exercise. Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes. Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention. Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy. | Device: Acapella Choice<br>* 3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.<br>* Other names: Semioccluded vocal tract exercise;Device: Tube-in-water<br>* 3 minutes of exercise consisting of blowing through a silicone tube (10mm internal diameter) submerged in 5 cm of water whilst phonating at the same time.<br>* Other names: Semi-occluded vocal tract exercise;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) | A quantitative, multivariate, dysphonia summary tool that incorporates spectral (low/high spectral ratio) and cepstral measures (cepstral peak prominence), and their standard deviations, extracted from a continuous speech or sustained vowel sample utilising the software Analysis of Dysphonia in Speech and Voice (Kay Pentax, Montvale, NJ). The software calculates CSID on the scale of 0-100, whereby 0 represents no evidence of hoarse voice, and 100 represents a maximum amount of hoarseness. See: Awan SN, Roy N, Dromey C. Estimating dysphonia severity in continuous speech: Application of a multi-parameter spectralcepstral model estimating dysphonia severity in continuous speech. Clinical Linguistics and Phonetics. 2009;23(11):825-841. doi:10.3109/02699200903242988. | Immediately after 3 minutes of exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Sound Pressure Level (dB) | Intensity of vocal signal | Immediately after 3 minutes of exercise | 
| Change in Baseline Mean Contact Quotient | A percentage which illustrates the duration of vocal fold contact during one vocal fold period as measured by electroglottogram (EGG). | During 3 minutes of exercise (continual) and immediately following exercise. | 
| Change in Subglottic Pressure | Measures of air pressure in the mouth. | During 3 minutes of exercise (continual) | 
| Transglottic Airflow | Measures of flow of air through the vocal tract. | During 3 minutes of exercise (continual) | 
| Change in Baseline Laryngeal Resistance | Derived from dividing mean intraoral pressure during /p/ by mean transglottic airflow during /a/ during a task which elicits repetition of 'pa-pa-pa-pa-pa' | Immediately after 3 minutes of exercise | 
| Change in Baseline Perceptual Voice Quality | Expert ratings of overall voice quality using a simple ad-hoc 100mm visual analog scale (ranging from 0-100, reflecting a scale of normal voice quality to highly abnormal voice quality {higher numbers reflect more abnormality}). | Immediately after 3 minutes of exercise | 
| Change in Baseline Participant Self-ratings - Voice Quality | Participant self-rating of voice quality (on a 100mm visual analog scale (0-100) where higher numbers reflect self-perception of better voice quality/ease of production) | Immediately after 3 minutes of exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
semi-occluded vocal tract exercise, positive expiratory pressure, tube phonation, Acapella, voice therapy