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Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

Primary Purpose

Muscle Tension Dysphonia, Vocal Fold Palsy, Vocal Cord Paralysis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acapella Choice
Tube-in-water
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Tension Dysphonia focused on measuring semi-occluded vocal tract exercise, positive expiratory pressure, tube phonation, Acapella, voice therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal National ENT Hospital, UCLH Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Muscle Tension Group

Vocal Fold Palsy Group

Presbylaryngis Group

Arm 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: 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Baseline Sound Pressure Level (dB)
Intensity of vocal signal
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).
Change in Subglottic Pressure
Measures of air pressure in the mouth.
Transglottic Airflow
Measures of flow of air through the vocal tract.
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'
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}).
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)

Full Information

First Posted
November 5, 2020
Last Updated
July 10, 2023
Sponsor
University College, London
Collaborators
Smiths Medical, ASD, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04764604
Brief Title
Evaluating the Feasibility of Acapella® Choice as a Dysphonia 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Smiths Medical, ASD, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tension Dysphonia, Vocal Fold Palsy, Vocal Cord Paralysis, Presbylarynx, Dysphonia
Keywords
semi-occluded vocal tract exercise, positive expiratory pressure, tube phonation, Acapella, voice therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle Tension Group
Arm Type
Experimental
Arm 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: 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.
Arm Title
Vocal Fold Palsy Group
Arm Type
Experimental
Arm 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: 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.
Arm Title
Presbylaryngis Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acapella Choice
Other Intervention Name(s)
PEP, Semioccluded vocal tract exercise
Intervention Description
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Intervention Type
Device
Intervention Name(s)
Tube-in-water
Other Intervention Name(s)
Lax Vox, Resonance tube in water, Semi-occluded vocal tract exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)
Description
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 Outcome Measure Information:
Title
Change in Baseline Sound Pressure Level (dB)
Description
Intensity of vocal signal
Time Frame
Immediately after 3 minutes of exercise
Title
Change in Baseline Mean Contact Quotient
Description
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.
Title
Change in Subglottic Pressure
Description
Measures of air pressure in the mouth.
Time Frame
During 3 minutes of exercise (continual)
Title
Transglottic Airflow
Description
Measures of flow of air through the vocal tract.
Time Frame
During 3 minutes of exercise (continual)
Title
Change in Baseline Laryngeal Resistance
Description
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'
Time Frame
Immediately after 3 minutes of exercise
Title
Change in Baseline Perceptual Voice Quality
Description
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}).
Time Frame
Immediately after 3 minutes of exercise
Title
Change in Baseline Participant Self-ratings - Voice Quality
Description
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)
Time Frame
Immediately after 3 minutes of exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Saccente-Kennedy, MSc
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal National ENT Hospital, UCLH Hospitals NHS Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
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Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

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