Alzheimer's DiseaseNCT02147652
Personalized Music Therapy and Agitation in Dementia
A study testing Personalized music in people with Alzheimer's Disease and Vascular Dementia, run by University Health Network, Toronto.
Trial summary
Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease, Vascular Dementia
- What is being tested?
- Personalized music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2014to Jun 2020
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
- moderate stage of dementia, a score of <20 on MMSE;
- Age 60 to 90 inclusive;
- Preserved hearing (hearing aids are permissible);
- Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.
Who cannot join
- auditory deficits requiring correction beyond hearing aids.
- no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
- recent acute event eg. MI, fractures, or major infection (not UTI)
- patients receiving standing orders of medication for personal care
About this study
Official title: Assessing the Effects of a Personalized Music Therapy With Headphones on Agitation in Patients With Dementia
Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming).
This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.
- Conditions
- Alzheimer's Disease, Vascular Dementia
- Being tested
- Personalized music
- Keywords
- moderate dementia, severe dementia, Alzheimer's disease, Vascular dementia, agitation, personalized music therapy
- Medical subject headings
- Alzheimer Disease, Dementia, Vascular, Dementia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized musicOther
| Study group | Role | What they receive |
|---|---|---|
| Personalized music | Experimental | Not described Receives: Other: Personalized music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in agitation
Changes in agitation as measured by the Pittsburgh agitation questionnaire and "as needed" psychotropic medications for agitation required during hygiene care will be quantitatively assessed. Statistical analyses will be performed to compare levels of agitation and use of "as needed" psychotropic medications for agitation with personalized music therapy with headphones and non-personalized music intervention or usual care.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start14 Oct 2014
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmela Tartaglia, University Health Network, Toronto
- Investigators
- Carmela Tartaglia, MD, FRCPC, Principal investigator, Assistant Professor, University of Toronto; Toronto Western Hospital, University Health Network; Tanz Centre for Research in Neurodegenerative Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147652
- Sponsor's protocol ID
- 14-7490-DE
- Status last verified
- Sep 2019
- First submitted
- 21 May 2014
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.
PubMed 40049590
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of a Personalized Music Therapy With Headphones on Agitation in Patients With Dementia
- ClinicalTrials.gov ID
- NCT02147652
- Acronym / sponsor ID
- 14-7490-DE
- Conditions
- Alzheimer's Disease, Vascular Dementia
- Keywords
- moderate dementia, severe dementia, Alzheimer's disease, Vascular dementia, agitation, personalized music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 28 May 2014 (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.
Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming).
This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized music | Experimental | Other: Personalized music |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
- moderate stage of dementia, a score of <20 on MMSE;
- Age 60 to 90 inclusive;
- Preserved hearing (hearing aids are permissible);
- Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.
Key exclusion criteria (4 listed)
- auditory deficits requiring correction beyond hearing aids.
- no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
- recent acute event eg. MI, fractures, or major infection (not UTI)
- patients receiving standing orders of medication for personal care
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 |
|---|---|---|
| Personalized music | Other | Personalized music |
Primary outcome
Changes in agitation
Time frame: 2 weeks
Changes in agitation as measured by the Pittsburgh agitation questionnaire and "as needed" psychotropic medications for agitation required during hygiene care will be quantitatively assessed. Statistical analyses will be performed to compare levels of agitation and use of "as needed" psychotropic medications for agitation with personalized music therapy with headphones and non-personalized music intervention or usual care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 40049590van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.
- Individual participant dataSharing planned: No
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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.
Carmela Tartaglia, MD, FRCPC principal investigator
Assistant Professor, University of Toronto; Toronto Western Hospital, University Health Network; Tanz Centre for Research in Neurodegenerative Disease
Questions about this trial
What is this clinical trial studying?
A study testing Personalized music in people with Alzheimer's Disease and Vascular Dementia, run by University Health Network, Toronto.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Changes in agitation (time frame: 2 weeks). 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 NCT02147652, which also lists 1 linked publication.
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 25 Sep 2019.