An interventional study of Acapella Choice and Tube-in-water in Muscle Tension Dysphonia, Vocal Fold Palsy and Vocal Cord Paralysis, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
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.
61 studies on the registry are indexed under Vocal Cord Paralysis; 16 are open to participants now.
This study's enrollment of 30 is below the median of 39 across 43 interventional studies indexed under Vocal Cord Paralysis.
Browse Vocal Cord Paralysis studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Endoscopically confirmed primary ENT diagnosis of either:
Exclusion Criteria:
Any of the following possible for PEP therapy:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Acapella Choice · Device: Tube-in-water
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.
Device: Acapella Choice · Device: Tube-in-water
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.
Device: Acapella Choice · Device: Tube-in-water
3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
Also known as: PEP, Semioccluded vocal tract exercise
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.
Also known as: Lax Vox, Resonance tube in water, Semi-occluded vocal tract exercise
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
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
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
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
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
| Milestone | Low Laryngeal Resistance | High Laryngeal Resistance Group |
|---|---|---|
| Started | 16 | 14 |
| Acapella choice task | 16 | 14 |
| Tube-in-water task | 16 | 14 |
| Completed | 16 | 14 |
| Not completed | 0 | 0 |
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.
| score on a scale | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | 1.22 ± 7.72 | 4.45 ± 12.2 |
| WRT Task | 4.56 ± 13.1 | 3.13 ± 8.21 |
Intensity of vocal signal
| dB | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | 0.79 ± 1.97 | 1.46 ± 2.72 |
| WRT Task | 1.57 ± 2.98 | -0.52 ± 2.76 |
A percentage which illustrates the duration of vocal fold contact during one vocal fold period as measured by electroglottogram (EGG).
| percentage of contact | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | 0.01 ± 0.04 | -0.01 ± 0.06 |
| WRT Task | 0.01 ± 0.06 | 0.00 ± 0.03 |
Measures of air pressure in the mouth.
| cmH2O | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | 0.16 ± 1.72 | 0.95 ± 1.81 |
| WRT Task | -0.74 ± 0.61 | -0.68 ± 1.77 |
Measures of flow of air through the vocal tract.
| l/s | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | 0.017 ± 0.163 | 0.023 ± 0.075 |
| WRT Task | -0.011 ± 0.097 | -0.003 ± 0.061 |
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'
| cmH20/l/s | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | 1.40 ± 23.9 | -6.01 ± 58.7 |
| WRT Task | -5.04 ± 14.5 | 23.77 ± 122 |
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}).
| units on a scale | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | -1.82 ± 6.03 | 0.175 ± 4.73 |
| WRT Task | 0.622 ± 4.65 | 5.18 ± 4.92 |
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)
| units on a scale | Low Laryngeal Resistance | High Laryngeal Resistance |
|---|---|---|
| Acapella Task | 12.3 ± 13.8 | 4.62 ± 9.05 |
| WRT Task | 6.56 ± 11.1 | 1.38 ± 9.97 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Laryngeal Resistance | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| High Laryngeal Resistance | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
Recruitment was undertaken along the lines of laryngeal diagnosis (10 patients in each diagnosis category). However, as laryngeal diagnosis results in diverse behavioural responses, treatment is never determined by diagnosis, alone. To better understand how participants responded to treatment, they were stratified into meaningful functional categories (Low and High Laryngeal Resistance), as these better represent the physiological targets of voice therapy.
| Age, Categorical(Participants) | Low Laryngeal Resistance | High Laryngeal Resistance | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 7 | 17 |
| >=65 years | 6 | 7 | 13 |
| Age, Continuous(years) | Low Laryngeal Resistance | High Laryngeal Resistance | Total |
|---|---|---|---|
| Mean | 52.31 ± 16.8 | 58.14 ± 18.9 | 55.0 ± 17.8 |
| Sex: Female, Male(Participants) | Low Laryngeal Resistance | High Laryngeal Resistance | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 8 | 6 | 14 |
| Race and Ethnicity Not Collected(Participants) | Low Laryngeal Resistance | High Laryngeal Resistance | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Low Laryngeal Resistance | High Laryngeal Resistance | Total |
|---|---|---|---|
| United Kingdom | 16 | 14 | 30 |
| Aerodynamic Resistance (Z-score)(Z scores) | Low Laryngeal Resistance | High Laryngeal Resistance | Total |
|---|---|---|---|
| Median | -0.63 (-1.09 to -0.18) | 1.07 (-0.16 to 2.30) | -0.21 (-0.81 to 0.39) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Nov 2021, 11 months.
Results were first posted in Aug 2023, 1 year 8 months after primary completion.
Of 20 interventional studies with no phase under Vocal Cord Paralysis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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