Idiopathic Parkinson DiseaseNCT03700684
Voice Treatment for Parkinson's Disease
A study testing Lee Silverman Voice Treatment and SpeechVive in people with Idiopathic Parkinson Disease, run by University of Massachusetts, Amherst at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- Lee Silverman Voice Treatment and SpeechVive
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease
- Problems with speech loudness due to Parkinson's disease
- No asthma or other respiratory problems
- No head, neck or chest surgery (Pacemaker surgery is okay)
- Non-smoking for the last 5 years
- Not currently participating in another treatment study
Show all 10Show fewer
- Typical cognitive skills
- Free of symptoms of depression
- Unaided hearing in at least one ear
- No voice therapy or voice therapy maintenance within the last 12 months
Who cannot join
- Other neurological diseases, other than Parkinson's disease
- History of asthma or respiratory problems
- Head, neck or chest surgery
- Smoker within the last 5 years
- Currently involved in another treatment study
- Decreased cognition
Show all 9Show fewer
- Symptoms of depression
- Wear a hearing aid in both ears
- Participated in voice therapy within the last 12 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Massachusetts Amherst
Amherst, Massachusetts, 01040
Purdue University
West Lafayette, Indiana, 47907
About this study
Official title: A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease
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.
Read the detailed description
Surgical and pharmacological management of the motor-based symptoms of PD has made great strides over the last few decades. The behavioral management of the speech and voice symptoms however, has not grown by the same leaps and bounds. Despite the prevalence of speech and voice symptoms associated with PD, few evidence-based treatment options are currently available. In the face of good efficacy data, the Lee Silverman Voice Treatment (LSVT LOUD) program continues to be the gold standard for voice treatment. LSVT LOUD trains patients to monitor and adjust their vocal intensity when they perceive that their voice is soft. Therefore, the success of LSVT LOUD is predicated, in part, on an individual's ability to self-monitor and self-cue (internal cueing) during speech production. While LSVT LOUD has fostered significant improvements in communication for many patients with PD, not all patients respond to treatment. It has been postulated that underlying sensory and cognitive factors may hinder treatment outcomes. A new behavioral treatment for speech and voice impairment has recently been introduced. The SpeechVive, a small in-the-ear device, uses an external noise cue to elicit louder speech. While LSVT LOUD and the SpeechVive have both been shown to significantly increase sound pressure level (SPL) in patients with PD, the physiologic adjustments supporting these changes in SPL remain unclear. This is an important area of study for two reasons. First, both treatments are exercised-based programs, yet the physiologic changes associated with these treatments are not well understood. Second, there is evidence to suggest that the use of an external cue, such as the noise cue used in SpeechVive training, elicits more efficient respiratory patterns in neurologically-healthy and neurologically-involved patients, in comparison to self-initiated cueing strategies, such as those used in LSVT LOUD. This study proposes to compare the influence of cueing strategy on treatment outcomes by examining simultaneous respiratory-laryngeal adjustments before and after participation in LSVT LOUD (internal cueing) and SpeechVive (external cueing) training. It is important to study respiratory-laryngeal interactions because both of these subsystems contribute to vocal intensity regulation. In addition, exercise physiology studies have indicated that internal and external forms of cueing elicit different perceptions of physical and mental effort during exercise. It is important to understand the patients' level of perceived physical and mental effort, associated with each treatment program, as these variables can effect adherence to the treatment regime. In summary, the proposed study is intended to 1) fill a critical void in the investigator's understanding of respiratory-laryngeal adjustments used to support increased SPL under two evidence-based behavioral voice treatment programs, and 2) to better understand how patients' perceptions of physical and mental effort are shaped by each treatment paradigm. The information generated in this study could potentially lead to more efficient voice rehabilitation for persons with PD.
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- Lee Silverman Voice Treatment, SpeechVive, Control
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lee Silverman Voice TreatmentBehavioural
Persons with Parkinson's disease receive sixteen hours of voice treatment over a four week period. Participants will practice the vocal exercises at home for an additional four weeks.
SpeechViveDevice
Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
ControlBehavioural
Persons assigned to the non-treatment control group will not participate in voice treatment.
| Study group | Role | What they receive |
|---|---|---|
| Lee Silverman Voice Treatment | Experimental | Persons with Parkinson's disease receive Lee Silverman Voice Treatment over an eight week period. Four weeks of face-to-face intervention and four weeks of home practice. Receives: Behavioral: Lee Silverman Voice Treatment |
| SpeechVive | Experimental | Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device. Receives: Device: SpeechVive |
| Control | Active comparator | Persons with Parkinsons disease do not receive voice intervention Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.
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 as they did not receive voice intervention.
Measured: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
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 and post-treatment values for lung volume initiation, termination, and excursion as a percentage of vital capacity relative to end-expiratory level.
Measured: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)
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.
Measured: Change from baseline after 8 weeks of treatment
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
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.
Measured: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)
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).
Measured: Change from baseline after 8 weeks of treatment
Secondary outcomes (5)
Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)
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 indicate a lower quality of life. Summary index scores are reported for baseline and post-treatment.
Measured: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire
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 indicate less interference in participation.
Measured: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire
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), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor.
Measured: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.
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.
Measured: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.
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).
Measured: Change from baseline after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start19 Sep 2018
- Primary completion15 Mar 2020
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are stratified by voice severity and assigned to one of three groups: Lee Silverman Voice Treatment (intervention), SpeechVive (intervention), or non-treatment control group (control).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Purdue University
- Responsible party
- Principal investigator, Kelly Richardson, University of Massachusetts, Amherst
- Investigators
- Kelly Richardson, Ph.D., Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700684
- Sponsor's protocol ID
- 2017-4212
- Other IDs
- 1R21DC016718-01
- Status last verified
- May 2023
- First submitted
- 4 Oct 2018
- Last updated
- 30 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data from the persons with Parkinson's disease will include perceptions of physical and mental effort, objective measures of speech, voice, and respiratory function.
Publications
Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
PubMed 24438910Richardson K, Sussman JE, Stathopoulos ET. The effect of increased vocal intensity on interarticulator timing in speakers with Parkinson's disease: a preliminary analysis. J Commun Disord. 2014 Nov-Dec;52:44-64. doi: 10.1016/j.jcomdis.2014.09.004.
PubMed 25459460Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
PubMed 21386044Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.
PubMed 17266087Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
PubMed 20844256
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03700684
- Acronym / sponsor ID
- 2017-4212
- Conditions
- Idiopathic Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Purdue University
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 30 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Surgical and pharmacological management of the motor-based symptoms of PD has made great strides over the last few decades. The behavioral management of the speech and voice symptoms however, has not grown by the same leaps and bounds. Despite the prevalence of speech and voice symptoms associated with PD, few evidence-based treatment options are currently available. In the face of good efficacy data, the Lee Silverman Voice Treatment (LSVT LOUD) program continues to be the gold standard for voice treatment. LSVT LOUD trains patients to monitor and adjust their vocal intensity when they perceive that their voice is soft. Therefore, the success of LSVT LOUD is predicated, in part, on an individual's ability to self-monitor and self-cue (internal cueing) during speech production. While LSVT LOUD has fostered significant improvements in communication for many patients with PD, not all patients respond to treatment. It has been postulated that underlying sensory and cognitive factors may hinder treatment outcomes. A new behavioral treatment for speech and voice impairment has recently been introduced. The SpeechVive, a small in-the-ear device, uses an external noise cue to elicit louder speech. While LSVT LOUD and the SpeechVive have both been shown to significantly increase sound pressure level (SPL) in patients with PD, the physiologic adjustments supporting these changes in SPL remain unclear. This is an important area of study for two reasons. First, both treatments are exercised-based programs, yet the physiologic changes associated with these treatments are not well understood. Second, there is evidence to suggest that the use of an external cue, such as the noise cue used in SpeechVive training, elicits more efficient respiratory patterns in neurologically-healthy and neurologically-involved patients, in comparison to self-initiated cueing strategies, such as those used in LSVT LOUD. This study proposes to compare the influence of cueing strategy on treatment outcomes by examining simultaneous respiratory-laryngeal adjustments before and after participation in LSVT LOUD (internal cueing) and SpeechVive (external cueing) training. It is important to study respiratory-laryngeal interactions because both of these subsystems contribute to vocal intensity regulation. In addition, exercise physiology studies have indicated that internal and external forms of cueing elicit different perceptions of physical and mental effort during exercise. It is important to understand the patients' level of perceived physical and mental effort, associated with each treatment program, as these variables can effect adherence to the treatment regime. In summary, the proposed study is intended to 1) fill a critical void in the investigator's understanding of respiratory-laryngeal adjustments used to support increased SPL under two evidence-based behavioral voice treatment programs, and 2) to better understand how patients' perceptions of physical and mental effort are shaped by each treatment paradigm. The information generated in this study could potentially lead to more efficient voice rehabilitation for persons with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are stratified by voice severity and assigned to one of three groups: Lee Silverman Voice Treatment (intervention), SpeechVive (intervention), or non-treatment control group (control).
| Arm | Type | Receives |
|---|---|---|
| Lee Silverman Voice Treatment | Experimental | Behavioral: Lee Silverman Voice TreatmentPersons with Parkinson's disease receive Lee Silverman Voice Treatment over an eight week period. Four weeks of face-to-face intervention and four weeks of home practice. |
| SpeechVive | Experimental | Device: SpeechVivePersons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device. |
| Control | Active comparator | Behavioral: ControlPersons with Parkinsons disease do not receive voice intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of Parkinson's disease
- Problems with speech loudness due to Parkinson's disease
- No asthma or other respiratory problems
- No head, neck or chest surgery (Pacemaker surgery is okay)
- Non-smoking for the last 5 years
Key exclusion criteria (9 listed)
- Other neurological diseases, other than Parkinson's disease
- History of asthma or respiratory problems
- Head, neck or chest surgery
- Smoker within the last 5 years
- Currently involved in another treatment study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lee Silverman Voice TreatmentPersons with Parkinson's disease receive sixteen hours of voice treatment over a four week period. Participants will practice the vocal exercises at home for an additional four weeks. | Behavioural | Lee Silverman Voice Treatment |
| SpeechVivePersons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication. | Device | SpeechVive |
| ControlPersons assigned to the non-treatment control group will not participate in voice treatment. | Behavioural | Control |
Primary outcome
Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.
Time frame: 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 as they did not receive voice intervention.
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Time frame: 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 and post-treatment values for lung volume initiation, termination, and excursion as a percentage of vital capacity relative to end-expiratory level.
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)
Time frame: 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.
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
Time frame: 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.
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)
Time frame: 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).
5 secondary outcomes
Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire
Time frame: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire
Time frame: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.
Time frame: Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.
Time frame: Change from baseline after 8 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24438910Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
- Results publication: PubMed 25459460Richardson K, Sussman JE, Stathopoulos ET. The effect of increased vocal intensity on interarticulator timing in speakers with Parkinson's disease: a preliminary analysis. J Commun Disord. 2014 Nov-Dec;52:44-64. doi: 10.1016/j.jcomdis.2014.09.004.
- Results publication: PubMed 21386044Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
- Results publication: PubMed 17266087Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.
- Results publication: PubMed 20844256Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
- Individual participant dataSharing planned: Yes. The data from the persons with Parkinson's disease will include perceptions of physical and mental effort, objective measures of speech, voice, and respiratory function.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Richardson, Ph.D. principal investigator
University of Massachusetts, Amherst
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lee Silverman Voice Treatment and SpeechVive in people with Idiopathic Parkinson Disease, run by University of Massachusetts, Amherst at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis. (time frame: Change from baseline after 8 weeks of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700684, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.