Voice Quality and Voice Loudness Associated With Parkinson's DiseaseSING-PDNCT01163331
Singing in Groups for Parkinson's Disease; A Pilot Study of Group Singing Therapy for PD-related Voice/Speech Impairment
A study testing Singing Therapy in people with Voice Quality and Voice Loudness Associated With Parkinson's Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study will compare group singing to group speech therapy without singing. You may be eligible for this study if you have been diagnosed with PD for one year or more and you have a quiet voice or difficulty being understood. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Voice Quality and Voice Loudness Associated With Parkinson's Disease
- What is being tested?
- Singing Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Difficulty being heard or understood
- Diagnosis of Parkinson's Disease for one year
Who cannot join
- No other neurological conditions(i.e. stroke, cerebellar ataxia) that affect voice quality
- No history of vocal chord hemorrhage
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Singing in Groups for Parkinson's Disease; A Pilot Study of Group Singing
This study will compare group singing to group speech therapy without singing. You may be eligible for this study if you have been diagnosed with PD for one year or more and you have a quiet voice or difficulty being understood.
Read the detailed description
The National Parkinson Foundation Center of Excellence at Beth Israel Deaconess Medical Center is conducting a research study to test whether group singing therapy helps people with voice or speech disorders due to Parkinson's disease (PD). Communication problems, including loss of vocal loudness, affect many people with PD. While existing forms of speech therapy have been shown to be helpful, group singing may be a beneficial alternative to traditional speech therapy.
The study will involve participating in weekly treatment sessions where subjects will receive training in vocal exercises from a speech-language pathologist with expertise in PD, as well as instructions for structured home practice. Participants will be assigned to a singing or non-singing group for the 12-week treatment phase of the study. Researchers will measure subjects' vocal function and communication-related quality of life before and several times after the 12-week program. All subjects and their care partners are welcome to participate in a singing group following the study.
You may be eligible for this study if you have been diagnosed with PD for one year or more, and you have difficulty with your voice or speech such as quiet voice, or difficulty being understood.
- Being tested
- Singing Therapy
- Keywords
- Parkinson's Disease, voice quality, vocal strength, voice loudness
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing TherapyOther
Singing therapy as a way to improve voice quality
| Study group | Role | What they receive |
|---|---|---|
| Singing Therapy Group | Experimental | Singing Therapy Group Receives: Other: Singing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal Loudness, Vocal Quality
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice Quality and Voice Loudness Associated With Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Daniel Tarsy, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163331
- Sponsor's protocol ID
- 2009P000338
- Acronym
- SING-PD
- Status last verified
- Mar 2017
- First submitted
- 14 Jul 2010
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singing in Groups for Parkinson's Disease; A Pilot Study of Group Singing
- ClinicalTrials.gov ID
- NCT01163331
- Acronym / sponsor ID
- SING-PD / 2009P000338
- Keywords
- Parkinson's Disease, voice quality, vocal strength, voice loudness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare group singing to group speech therapy without singing. You may be eligible for this study if you have been diagnosed with PD for one year or more and you have a quiet voice or difficulty being understood.
Detailed description
The National Parkinson Foundation Center of Excellence at Beth Israel Deaconess Medical Center is conducting a research study to test whether group singing therapy helps people with voice or speech disorders due to Parkinson's disease (PD). Communication problems, including loss of vocal loudness, affect many people with PD. While existing forms of speech therapy have been shown to be helpful, group singing may be a beneficial alternative to traditional speech therapy.
The study will involve participating in weekly treatment sessions where subjects will receive training in vocal exercises from a speech-language pathologist with expertise in PD, as well as instructions for structured home practice. Participants will be assigned to a singing or non-singing group for the 12-week treatment phase of the study. Researchers will measure subjects' vocal function and communication-related quality of life before and several times after the 12-week program. All subjects and their care partners are welcome to participate in a singing group following the study.
You may be eligible for this study if you have been diagnosed with PD for one year or more, and you have difficulty with your voice or speech such as quiet voice, or difficulty being understood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singing Therapy Group | Experimental | Other: Singing TherapySinging Therapy Group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Difficulty being heard or understood
- Diagnosis of Parkinson's Disease for one year
Key exclusion criteria (2 listed)
- No other neurological conditions(i.e. stroke, cerebellar ataxia) that affect voice quality
- No history of vocal chord hemorrhage
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 |
|---|---|---|
| Singing TherapySinging therapy as a way to improve voice quality | Other | Singing Therapy Group |
Primary outcome
Vocal Loudness, Vocal Quality
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Related InfoLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing Therapy in people with Voice Quality and Voice Loudness Associated With Parkinson's Disease, run by Beth Israel Deaconess Medical Center at 1 site 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 2 inclusion and 2 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 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vocal Loudness, Vocal Quality (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2017.