Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

University College, London30 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Muscle Tension Dysphonia Vocal Fold Palsy Vocal Cord Paralysis Presbylarynx Dysphonia

Interventions

Acapella ChoiceDEVICE

3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.

Tube-in-waterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able to understand written English without the need for an interpreter, * No diagnosed communication impairment * Endoscopically confirmed primary ENT diagnosis of either: 1. muscle tension dysphonia (with no laryngeal abnormality), 2. Vocal fold palsy 3. 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

Locations (1)

Royal National ENT Hospital, UCLH Hospitals NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Immediately after 3 minutes of exercise

Secondary Outcomes

Change in Baseline Sound Pressure Level (dB)

Intensity of vocal signal

Time frame: 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).

Time frame: During 3 minutes of exercise (continual) and immediately following exercise.

Change in Subglottic Pressure

Measures of air pressure in the mouth.

Time frame: During 3 minutes of exercise (continual)

Transglottic Airflow

Measures of flow of air through the vocal tract.

Time frame: During 3 minutes of exercise (continual)

Change in Baseline Laryngeal Resistance

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.