Trial Outcomes & Findings for Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment (NCT NCT04764604)
NCT ID: NCT04764604
Last Updated: 2023-08-01
Results Overview
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.
COMPLETED
NA
30 participants
Immediately after 3 minutes of exercise
2023-08-01
Participant Flow
Participant milestones
| Measure |
Low Laryngeal Resistance
Recruited participants will be stratified into Low and High Laryngeal Resistance Groups on the basis of their baseline (i.e. before intervention) laryngeal resistance as compared to published norms. Laryngeal resistance is derived from dividing mean intraoral pressure (in cmH2O) during /p/ by mean transglottic airflow (in l/s) during /a/ during a task which elicits repetition of 'pa-pa-pa-pa-pa'. This resistance will then be converted into a Z-score in relation to published norms. Those participants with a laryngeal resistance below a Z-score of 0 (i.e age- and gender-matched published normative mean) will be categorised into the 'low laryngeal resistance group'.
All participants will perform the following tasks:
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.
|
High Laryngeal Resistance Group
Recruited participants will be stratified into Low and High Laryngeal Resistance Groups on the basis of their baseline (i.e. before intervention) laryngeal resistance as compared to published norms. Laryngeal resistance is derived from dividing mean intraoral pressure (in cmH2O) during /p/ by mean transglottic airflow (in l/s) during /a/ during a task which elicits repetition of 'pa-pa-pa-pa-pa'. This resistance will then be converted into a Z-score in relation to published norms. Those participants with a laryngeal resistance above a Z-score of 0 (i.e age- and gender-matched published normative mean) will be categorised into the 'high laryngeal resistance group'.
All participants will perform the following tasks:
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.
|
|---|---|---|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
Acapella Choice Task
|
16
|
14
|
|
Overall Study
Tube-in-Water Task
|
16
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Laryngeal Resistance
n=16 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=14 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=16 Participants
|
7 Participants
n=14 Participants
|
17 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=16 Participants
|
7 Participants
n=14 Participants
|
13 Participants
n=30 Participants
|
|
Age, Continuous
|
52.31 years
STANDARD_DEVIATION 16.8 • n=16 Participants
|
58.14 years
STANDARD_DEVIATION 18.9 • n=14 Participants
|
55.0 years
STANDARD_DEVIATION 17.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=16 Participants
|
8 Participants
n=14 Participants
|
16 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=16 Participants
|
6 Participants
n=14 Participants
|
14 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=16 Participants
|
14 participants
n=14 Participants
|
30 participants
n=30 Participants
|
|
Aerodynamic Resistance (Z-score)
|
-0.63 Z scores
n=16 Participants
|
1.07 Z scores
n=14 Participants
|
-0.21 Z scores
n=30 Participants
|
PRIMARY outcome
Timeframe: Immediately after 3 minutes of exerciseA 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.
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)
Acapella Task
|
1.22 score on a scale
Standard Deviation 7.72
|
4.45 score on a scale
Standard Deviation 12.2
|
|
Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)
WRT Task
|
4.56 score on a scale
Standard Deviation 13.1
|
3.13 score on a scale
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: Immediately after 3 minutes of exercisePopulation: Each subgroup (Low and High Laryngeal Resistance) underwent two therapeutic interventions (Acapella and Water Resistance Therapy (WRT)) each.
Intensity of vocal signal
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Change in Baseline Sound Pressure Level (dB)
Acapella Task
|
0.79 dB
Standard Deviation 1.97
|
1.46 dB
Standard Deviation 2.72
|
|
Change in Baseline Sound Pressure Level (dB)
WRT Task
|
1.57 dB
Standard Deviation 2.98
|
-0.52 dB
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Change in Baseline Mean Contact Quotient
Acapella Task
|
0.01 percentage of contact
Standard Deviation 0.04
|
-0.01 percentage of contact
Standard Deviation 0.06
|
|
Change in Baseline Mean Contact Quotient
WRT Task
|
0.01 percentage of contact
Standard Deviation 0.06
|
0.00 percentage of contact
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: 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.
Measures of air pressure in the mouth.
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Change in Subglottic Pressure
Acapella Task
|
0.16 cmH2O
Standard Deviation 1.72
|
0.95 cmH2O
Standard Deviation 1.81
|
|
Change in Subglottic Pressure
WRT Task
|
-0.74 cmH2O
Standard Deviation 0.61
|
-0.68 cmH2O
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: During 3 minutes of exercise (continual)Measures of flow of air through the vocal tract.
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Transglottic Airflow
Acapella Task
|
0.017 l/s
Standard Deviation 0.163
|
0.023 l/s
Standard Deviation 0.075
|
|
Transglottic Airflow
WRT Task
|
-0.011 l/s
Standard Deviation 0.097
|
-0.003 l/s
Standard Deviation 0.061
|
SECONDARY outcome
Timeframe: Immediately after 3 minutes of exercisePopulation: 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.
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'
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Change in Baseline Laryngeal Resistance
Acapella Task
|
1.40 cmH20/l/s
Standard Deviation 23.9
|
-6.01 cmH20/l/s
Standard Deviation 58.7
|
|
Change in Baseline Laryngeal Resistance
WRT Task
|
-5.04 cmH20/l/s
Standard Deviation 14.5
|
23.77 cmH20/l/s
Standard Deviation 122
|
SECONDARY outcome
Timeframe: Immediately after 3 minutes of exerciseExpert 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}).
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Change in Baseline Perceptual Voice Quality
Acapella Task
|
-1.82 units on a scale
Standard Deviation 6.03
|
0.175 units on a scale
Standard Deviation 4.73
|
|
Change in Baseline Perceptual Voice Quality
WRT Task
|
0.622 units on a scale
Standard Deviation 4.65
|
5.18 units on a scale
Standard Deviation 4.92
|
SECONDARY outcome
Timeframe: Immediately after 3 minutes of exerciseParticipant 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)
Outcome measures
| Measure |
Low Laryngeal Resistance
n=14 Participants
N=14. Laryngeal resistance with Z-scores for laryngeal resistance below 0.
|
High Laryngeal Resistance
n=16 Participants
N=16. Laryngeal resistance with Z-scores for laryngeal resistance above 0.
|
|---|---|---|
|
Change in Baseline Participant Self-ratings - Voice Quality
WRT Task
|
6.56 units on a scale
Standard Deviation 11.1
|
1.38 units on a scale
Standard Deviation 9.97
|
|
Change in Baseline Participant Self-ratings - Voice Quality
Acapella Task
|
12.3 units on a scale
Standard Deviation 13.8
|
4.62 units on a scale
Standard Deviation 9.05
|
Adverse Events
Low Laryngeal Resistance
High Laryngeal Resistance
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Saccente-Kennedy, Speech and Language Therapist
University College London Hospitals NHS Foundation Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place