Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

University College London (UCL)

Status: Completed

Conditions: Vocal Cord Paralysis; Presbylarynx; Dysphonia; Vocal Fold Palsy; Muscle Tension Dysphonia

Treatments: Device: Acapella Choice; Device: Tube-in-water

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04764604

18/0434

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Muscle Tension Group

Experimental group

Description:

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: 1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice 2. 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.

Treatment:

Device: Tube-in-water

Device: Acapella Choice

Vocal Fold Palsy Group

Experimental group

Description:

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: 1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice 2. 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.

Treatment:

Device: Tube-in-water

Device: Acapella Choice

Presbylaryngis Group

Experimental group

Description:

10 participants with a diagnosis of presbylaryngis will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions: 1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice 2. 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.

Treatment:

Device: Tube-in-water

Device: Acapella Choice