Dysphonia, Muscle Tension Dysphonia, Presbylarynx, Vocal Cord Paralysis, Vocal Fold Palsy
Conditions
Keywords
semi-occluded vocal tract exercise, positive expiratory pressure, tube phonation, Acapella, voice therapy
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.
Interventions
DEVICEAcapella Choice
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
DEVICETube-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.
Sponsors
Smiths Medical, ASD, Inc.
University College, London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) | Immediately after 3 minutes of exercise | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline Mean Contact Quotient | During 3 minutes of exercise (continual) and immediately following exercise. | A percentage which illustrates the duration of vocal fold contact during one vocal fold period as measured by electroglottogram (EGG). |
| Change in Subglottic Pressure | During 3 minutes of exercise (continual) | Measures of air pressure in the mouth. |
| Transglottic Airflow | During 3 minutes of exercise (continual) | Measures of flow of air through the vocal tract. |
| Change in Baseline Sound Pressure Level (dB) | Immediately after 3 minutes of exercise | Intensity of vocal signal |
| 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}). |
| Change in Baseline Participant Self-ratings - Voice Quality | Immediately after 3 minutes of exercise | 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) |
| 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' |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Laryngeal Resistance N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0. | 16 |
| High Laryngeal Resistance N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | High Laryngeal Resistance | Low Laryngeal Resistance |
|---|---|---|---|
| Aerodynamic Resistance (Z-score) | -0.21 Z scores | 1.07 Z scores | -0.63 Z scores |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 7 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 7 Participants | 10 Participants |
| Age, Continuous | 55.0 years STANDARD_DEVIATION 17.8 | 58.14 years STANDARD_DEVIATION 18.9 | 52.31 years STANDARD_DEVIATION 16.8 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United Kingdom | 30 participants | 14 participants | 16 participants |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) | Acapella Task | 1.22 score on a scale | Standard Deviation 7.72 |
| Low Laryngeal Resistance | Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) | WRT Task | 4.56 score on a scale | Standard Deviation 13.1 |
| High Laryngeal Resistance | Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) | Acapella Task | 4.45 score on a scale | Standard Deviation 12.2 |
| High Laryngeal Resistance | Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) | WRT Task | 3.13 score on a scale | Standard Deviation 8.21 |
Secondary
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'
Time frame: Immediately after 3 minutes of exercise
Population: In this outcome, pre-port comparison is made with actual units of resistance. Previously, Z-scores were utilised to explain the baseline differences between the groups (i.e. low vs high resistance groups). In the case of this outcome measure, a per-participant difference in pre- and post-exercise resistance is utilised.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Change in Baseline Laryngeal Resistance | Acapella Task | 1.40 cmH20/l/s | Standard Deviation 23.9 |
| Low Laryngeal Resistance | Change in Baseline Laryngeal Resistance | WRT Task | -5.04 cmH20/l/s | Standard Deviation 14.5 |
| High Laryngeal Resistance | Change in Baseline Laryngeal Resistance | Acapella Task | -6.01 cmH20/l/s | Standard Deviation 58.7 |
| High Laryngeal Resistance | Change in Baseline Laryngeal Resistance | WRT Task | 23.77 cmH20/l/s | Standard Deviation 122 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Change in Baseline Mean Contact Quotient | Acapella Task | 0.01 percentage of contact | Standard Deviation 0.04 |
| Low Laryngeal Resistance | Change in Baseline Mean Contact Quotient | WRT Task | 0.01 percentage of contact | Standard Deviation 0.06 |
| High Laryngeal Resistance | Change in Baseline Mean Contact Quotient | Acapella Task | -0.01 percentage of contact | Standard Deviation 0.06 |
| High Laryngeal Resistance | Change in Baseline Mean Contact Quotient | WRT Task | 0.00 percentage of contact | Standard Deviation 0.03 |
Secondary
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)
Time frame: Immediately after 3 minutes of exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Change in Baseline Participant Self-ratings - Voice Quality | WRT Task | 6.56 units on a scale | Standard Deviation 11.1 |
| Low Laryngeal Resistance | Change in Baseline Participant Self-ratings - Voice Quality | Acapella Task | 12.3 units on a scale | Standard Deviation 13.8 |
| High Laryngeal Resistance | Change in Baseline Participant Self-ratings - Voice Quality | WRT Task | 1.38 units on a scale | Standard Deviation 9.97 |
| High Laryngeal Resistance | Change in Baseline Participant Self-ratings - Voice Quality | Acapella Task | 4.62 units on a scale | Standard Deviation 9.05 |
Secondary
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}).
Time frame: Immediately after 3 minutes of exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Change in Baseline Perceptual Voice Quality | Acapella Task | -1.82 units on a scale | Standard Deviation 6.03 |
| Low Laryngeal Resistance | Change in Baseline Perceptual Voice Quality | WRT Task | 0.622 units on a scale | Standard Deviation 4.65 |
| High Laryngeal Resistance | Change in Baseline Perceptual Voice Quality | Acapella Task | 0.175 units on a scale | Standard Deviation 4.73 |
| High Laryngeal Resistance | Change in Baseline Perceptual Voice Quality | WRT Task | 5.18 units on a scale | Standard Deviation 4.92 |
Secondary
Change in Baseline Sound Pressure Level (dB)
Intensity of vocal signal
Time frame: Immediately after 3 minutes of exercise
Population: Each subgroup (Low and High Laryngeal Resistance) underwent two therapeutic interventions (Acapella and Water Resistance Therapy (WRT)) each.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Change in Baseline Sound Pressure Level (dB) | Acapella Task | 0.79 dB | Standard Deviation 1.97 |
| Low Laryngeal Resistance | Change in Baseline Sound Pressure Level (dB) | WRT Task | 1.57 dB | Standard Deviation 2.98 |
| High Laryngeal Resistance | Change in Baseline Sound Pressure Level (dB) | Acapella Task | 1.46 dB | Standard Deviation 2.72 |
| High Laryngeal Resistance | Change in Baseline Sound Pressure Level (dB) | WRT Task | -0.52 dB | Standard Deviation 2.76 |
Secondary
Change in Subglottic Pressure
Measures of air pressure in the mouth.
Time frame: During 3 minutes of exercise (continual)
Population: Each subgroup (Low and High Laryngeal Resistance) underwent two therapeutic interventions (Acapella and Water Resistance Therapy (WRT)) each.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Change in Subglottic Pressure | Acapella Task | 0.16 cmH2O | Standard Deviation 1.72 |
| Low Laryngeal Resistance | Change in Subglottic Pressure | WRT Task | -0.74 cmH2O | Standard Deviation 0.61 |
| High Laryngeal Resistance | Change in Subglottic Pressure | Acapella Task | 0.95 cmH2O | Standard Deviation 1.81 |
| High Laryngeal Resistance | Change in Subglottic Pressure | WRT Task | -0.68 cmH2O | Standard Deviation 1.77 |
Secondary
Transglottic Airflow
Measures of flow of air through the vocal tract.
Time frame: During 3 minutes of exercise (continual)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Laryngeal Resistance | Transglottic Airflow | Acapella Task | 0.017 l/s | Standard Deviation 0.163 |
| Low Laryngeal Resistance | Transglottic Airflow | WRT Task | -0.011 l/s | Standard Deviation 0.097 |
| High Laryngeal Resistance | Transglottic Airflow | Acapella Task | 0.023 l/s | Standard Deviation 0.075 |
| High Laryngeal Resistance | Transglottic Airflow | WRT Task | -0.003 l/s | Standard Deviation 0.061 |