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Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT04764604
Collaborator
Smiths Medical, ASD, Inc. (Industry)
30
Enrollment
1
Location
3
Arms
11.5
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Acapella Choice
  • Device: Tube-in-water
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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)
Primary Purpose:
Treatment
Official Title:
Evaluating the Therapeutic Use of a Vibratory Positive Expiratory Pressure Device (Acapella® Choice) in the Treatment of Pathological Voice - A Feasibility Study
Actual Study Start Date :
Dec 14, 2020
Actual Primary Completion Date :
Nov 29, 2021
Actual Study Completion Date :
Nov 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Muscle Tension Group

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
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Other Names:
  • PEP
  • Semioccluded vocal tract exercise

    • Device: Tube-in-water
    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.
    Other Names:
  • Lax Vox
  • Resonance tube in water
  • Semi-occluded vocal tract exercise

    		•
    Experimental: Vocal Fold Palsy Group

    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
    3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
    Other Names:
  • PEP
  • Semioccluded vocal tract exercise

    • Device: Tube-in-water
    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.
    Other Names:
  • Lax Vox
  • Resonance tube in water
  • Semi-occluded vocal tract exercise

    		•
    Experimental: Presbylaryngis Group

    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
    3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
    Other Names:
  • PEP
  • Semioccluded vocal tract exercise

    • Device: Tube-in-water
    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.
    Other Names:
  • Lax Vox
  • Resonance tube in water
  • Semi-occluded vocal tract exercise

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Baseline Cepstral/spectral index of dysphonia (CSID) [Immediately after 3 minutes of exercise]

      A quantitative, multivariate, dysphonia summary tool that incorporates spectral and cepstral measures extracted from a continuous speech or sustained vowel sample.

    Secondary Outcome Measures

    1. Change in Baseline Sound pressure level (dB) [Immediately after 3 minutes of exercise]

      Intensity of vocal signal

    2. Change in Baseline Mean contact quotient [During 3 minutes of exercise (continual) and immediately following exercise.]

      A ratio which illustrates the duration of vocal fold contact during one vocal fold period as measured by electroglottogram (EGG).

    3. Intraoral pressure [During 3 minutes of exercise (continual)]

      Measures of air pressure in the mouth.

    4. Transglottic airflow [During 3 minutes of exercise (continual)]

      Measures of flow of air through the vocal tract.

    5. Change in Baseline Laryngeal resistance [Immediately after 3 minutes of exercise]

      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'

    6. Change in Baseline Perceptual voice quality [Immediately after 3 minutes of exercise]

      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}).

    7. Change in Baseline Participant self-ratings [Immediately after 3 minutes of exercise]

      Ad-hoc questionnaire-based qualitative participant self-rating of voice quality, ease of voice production (on a 100mm visual analog scale (0-100) where higher numbers reflect self-perception of better voice quality/ease of production) and qualitative views on carrying out the interventions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal National ENT Hospital, UCLH Hospitals NHS Trust London United Kingdom NW1 2PG

    Sponsors and Collaborators

    • University College, London
    • Smiths Medical, ASD, Inc.

    Investigators

    • Principal Investigator: Brian Saccente-Kennedy, MSc, University College London Hospitals

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT04764604
    Other Study ID Numbers:
    • 18/0434
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University College, London
    semi-occluded vocal tract exercise
    positive expiratory pressure
    tube phonation
    Acapella
    voice therapy
    Additional relevant MeSH terms:
    Dysphonia
    Hoarseness
    Vocal Cord Paralysis
    Paralysis

    Study Results

    No Results Posted as of May 18, 2022