50 and older, any sex, with Idiopathic Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.Primary· Change from baseline after 8 weeks of treatment
Vocal intensity (dB SPL) will be measured during a reading task and a monologue task. The vocal intensity data reported will be collapsed across the reading and monologue task. Recorded speech samples are captured using a head-mounted microphone. The speech signals are analyzed for vocal intensity using Praat. The pre- to post-treatment change in vocal intensity is reported in decibels. A positive value indicates an increase in vocal intensity post-treatment. A negative value indicates a decrease in vocal intensity post-treatment. We expected to see no change in vocal intensity for the control
Group
Value
95% CI
Lee Silverman Voice Treatment
3
± 1.4
SpeechVive
3
± 2.5
Control
0.26
± 0.23
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.Primary· Change from baseline after 8 weeks of treatment
Changes in speech breathing will be assessed by examining movement in the ribcage and abdominal walls (respiratory kinematics) during speech. Non-invasive elasticized bands are fitted around the chest and abdominal walls to monitor movement. Respiratory kinematic measures will be in percentage of vital capacity relative to end-expiratory level. Negative values for lung volume termination indicate that speech was terminated below end-expiratory level. Positive values for lung volume termination indicate that speech was terminated above end-expiratory level. The data reported show the baseline a
Lung volume initiation (baseline)
Group
Value
95% CI
Lee Silverman Voice Treatment
22.89
± 20.14
SpeechVive
21.75
± 13.31
Lung volume initiation (post-treatment)
Group
Value
95% CI
Lee Silverman Voice Treatment
17.87
± 15.81
SpeechVive
20.73
± 8.90
Lung volume termination (baseline)
Group
Value
95% CI
Lee Silverman Voice Treatment
5.84
± 16.95
SpeechVive
6.41
± 11.78
Lung volume termination (post-treatment)
Group
Value
95% CI
Lee Silverman Voice Treatment
-6.37
± 16.75
SpeechVive
5.37
± 7.90
Lung volume excursion (baseline)
Group
Value
95% CI
Lee Silverman Voice Treatment
17.05
± 12.79
SpeechVive
15.34
± 10.21
Lung volume excursion (post-treatment)
Group
Value
95% CI
Lee Silverman Voice Treatment
24.24
± 17.60
SpeechVive
15.36
± 9.68
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)Primary· Change from baseline after 8 weeks of treatment
Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how long the vocal folds are open (open quotient). Pre-treatment and post-treatment values are reported. Open quotient is a unit-less measure.
Open Quotient (baseline)
Group
Value
95% CI
Lee Silverman Voice Treatment
0.72
± 0.05
SpeechVive
0.71
± 0.13
Open Quotient (post-treatment)
Group
Value
95% CI
Lee Silverman Voice Treatment
0.72
± 0.11
SpeechVive
0.68
± 0.12
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load IndexPrimary· Change from baseline after 8 weeks of treatment
Ratings of physical and mental effort will be assigned by participants on treatment days using the modified NASA-Task Load Index. Participants rate how much physical effort and mental effort it took to complete treatment each day. Participants will indicate their response using a visual analogue scale (0-100) with the endpoints "no effort" ("0") to "significant effort" ("100"). Data are not reported for the clinical control group as these participants did not receive treatment. Ratings of mental and physical effort are reported separately at baseline and post-treatment.
Mental effort (baseline)
Group
Value
95% CI
Lee Silverman Voice Treatment
60.07
± 23.53
SpeechVive
35.23
± 30.19
Mental effort (post-treatment)
Group
Value
95% CI
Lee Silverman Voice Treatment
67.03
± 15.54
SpeechVive
16.59
± 17.70
Physical effort (baseline)
Group
Value
95% CI
Lee Silverman Voice Treatment
65.32
± 18.24
SpeechVive
22.31
± 11.13
Physical effort (post-treatment)
Group
Value
95% CI
Lee Silverman Voice Treatment
67.59
± 20.24
SpeechVive
10.5
± 8.15
Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)Secondary· Change from baseline after 8 weeks of treatment
This 39-item self-report questionnaire is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. The PDQ-39 scores each item on a 5 point scale (0=never, 4=always) and is scored along 8 different scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. A summary index score is calculated by averaging the scores across these 8 difference scales. The minimum score is 0 and the maximum score is 100. Lower scores indicate a better quality of life and higher scores indic
Baseline
Group
Value
95% CI
Lee Silverman Voice Treatment
18.61
± 10.27
SpeechVive
23.04
± 9.04
Control
26.74
± 16.95
Post-treatment
Group
Value
95% CI
Lee Silverman Voice Treatment
18.13
± 12.70
SpeechVive
21.60
± 11.32
Control
23.95
± 16.64
Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form QuestionnaireSecondary· Change from baseline after 8 weeks of treatment
The Communicative Participation Item Bank-Short Form is a 10-item self-report questionnaire that examines how a given condition (e.g. Parkinson's disease) interferes with communication in various situations (e.g. noisy environment). The questionnaire has 10 questions that depict a variety of speaking situations. Each of the 10 questions is assigned a score between 0 (very much) to 3 (not at all). Participants are asked to indicate how much their condition interferes with participation in each situation. The scores are summed to come up with a summary score between 0 and 30. High scores indicat
Baseline
Group
Value
95% CI
Lee Silverman Voice Treatment
19.17
± 5.98
SpeechVive
16.09
± 7.99
Control
18.3
± 4.95
Post-treatment
Group
Value
95% CI
Lee Silverman Voice Treatment
23
± 4.81
SpeechVive
16.45
± 6.12
Control
18.78
± 8.48
Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) QuestionnaireSecondary· Change from baseline after 8 weeks of treatment
The Voice-related Quality of Life VR-QOL instrument is a 10-item self-report questionnaire that examines the impact of a persons voice impairment on activities of daily living. For each item, participants assign a score between 1 (Not a problem) and 5 (Problem is as bad as can be). A total score is calculated by summing the assigned scores across the 10 items. The minimum total score is 10 and the maximum total score is 50. Higher scores indicate that the voice problem interferes with activities of daily living. The overall VR-QOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 2
Baseline
Group
Value
95% CI
Lee Silverman Voice Treatment
19
± 7.83
SpeechVive
23.91
± 9.09
Control
25.1
± 6.37
Post-treatment
Group
Value
95% CI
Lee Silverman Voice Treatment
16.13
± 5.19
SpeechVive
21.27
± 5.98
Control
21.33
± 7.73
Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.Secondary· Change from baseline after 8 weeks of treatment
While wearing a microphone, participants will read a short passage. The speech samples will be analyzed for speech rate using an acoustic software program. Speech rate is measured and reported in syllables per second. Higher values indicate a faster speech rate and lower values indicate a slower speech rate.
Baseline
Group
Value
95% CI
Lee Silverman Voice Treatment
3.27
± 0.93
SpeechVive
3.53
± 0.86
Post-treatment
Group
Value
95% CI
Lee Silverman Voice Treatment
3.26
± 0.88
SpeechVive
3.42
± 1.02
Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.Secondary· Change from baseline after 8 weeks of treatment
While wearing a microphone, participants will read a short passage. These recorded speech samples will be analyzed for the frequency of pauses using an acoustic analysis software program. Pauses are reported as a frequency count (how many occur in a given sample).
Baseline
Group
Value
95% CI
Lee Silverman Voice Treatment
26
± 7.65
SpeechVive
27.19
± 14.03
Control
26.6
± 8.30
Post-treatment
Group
Value
95% CI
Lee Silverman Voice Treatment
29.88
± 6.24
SpeechVive
27.18
± 9.06
Control
27.11
± 11.99
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)Primary· Change from baseline after 8 weeks of treatment
Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how quickly the vocal folds are closing (maximum flow declination rate). Pre-treatment and post-treatment values are reported. Maximum flow declination rate (MFDR) is reported in liters per second per second (L/s/s).
Maximum flow declination rate (baseline)
Group
Value
95% CI
Lee Silverman Voice Treatment
194.31
± 83.69
SpeechVive
239.90
± 200.25
Maximum flow declination rate (post-treatment)
Group
Value
95% CI
Lee Silverman Voice Treatment
179.53
± 42.42
SpeechVive
181.24
± 54.73
Adverse events — posted to ClinicalTrials.gov
Time frame: 8 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study addresses several issues related to the clinical management of speech and voice disorders associated with Parkinson's disease. Two behavioral treatment programs, Lee Silverman Voice Treatment and SpeechVive, are assessed in their ability to improve communication in persons with Parkinson's disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Massachusetts, Amherst
Last refreshed: 30 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03700684.