DementiaNCT06104436
Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia
A study testing Individualized music playlist and Preferred music in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Individualized music playlist and Preferred music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- residents in long-term care facilities
- diagnosed with any type of dementia
- presented with significant agitation
Who cannot join
- had been admitted to the facility for less than three months
- are participating in other studies or experimental therapies
- have a comorbid psychiatric illness
- have physical illness that prevents them from listening to music
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: The Effects of an Individualized Music Playlist Based on the ISOPrinciple for the Immediate De-escalation of Agitation in People With Dementia: a Randomized Controlled Trial
The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU).
Read the detailed description
- Study design
- Randomized controlled trial
- Participants
- Eighty-one older adults living with dementia and demonstrate significant agitation
- Setting:
- Residential care home
- Intervention
- Individualized music listening intervention played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.
- Comparison conditions
- Preferred music listening group: Preferred music listening played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.
- Usual care group: usual care
- Outcomes
- Level of agitation measured with the Pittsburgh Agitation Scale
- Intensity of agitation measured with the Positive and Negative Syndrome Scale - Excited Component
- Agitation occurrence frequency measured with Cohen-Mansfield Agitation Inventory
- Distress of formal caregivers related to agitation measured with Neuropsychiatric Inventory
- Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.
- Conditions
- Dementia
- Being tested
- Individualized music playlist, Preferred music, Usual care
- Keywords
- Dementia, Agitation, Music
- Medical subject headings
- Dementia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized music playlistBehavioural
Individualized music playlist composed of preferred music genres sequenced according to the ISO-Principle. It will be played at the state of agitation.
Preferred musicBehavioural
Preferred music is composed of the genres selected by the participants, and to be played at random sequence.
Usual careBehavioural
Usual technique for calming agitated older adults with dementia
| Study group | Role | What they receive |
|---|---|---|
| Individualized music playlist | Experimental | Composed of preferred music genres sequenced according to the ISO-Principle in addition to usual care. Receives: Behavioral: Individualized music playlist; Behavioral: Usual care |
| Preferred music | Active comparator | Preferred music genres played in random sequence in addition to usual care. Receives: Behavioral: Preferred music; Behavioral: Usual care |
| Treatment as usual | Sham comparator | Usual care for agitation management. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of agitation
Positive and Negative Syndrome Scale - Excitatory Component will be used for assessing the level of agitation. It consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation.
Measured: 6 weeks
Intensity of agitation
Pittsburgh Agitation Scale will be used to assess the intensity of agitation. It is a brief measure of agitation that measures the severity of agitation in four general categories: aberrant vocalisation, motor agitation, aggressiveness and resisting care, on a scale from 0 (not present) to 4 (highest level).
Measured: 6 weeks
Agitation status
Behavioural Activity Rating Scale will be used to assess the agitation status. It contains a single-item question consisting of seven categories: 1=difficult or unable to rouse; 2=asleep, but responds normally to verbal or physical contact; 3=drowsy, appears sedated; 4=quiet and awake (normal level of activity); 5=signs of overt (physical or verbal) activity, calms down with instruction; 6=extremely or continuously active, not requiring restraint; 7=violent, requires restraint.
Measured: 6 weeks
Secondary outcomes (2)
Agitation occurrence
Cohen-Mansfield Agitation Inventory will be used to assess the agitation occurence. A total CMAI score is obtained by summing all the individual items, giving a range from 29 to 203. A total score of >45 is usually regarded as clinically significant agitation.
Measured: 6 weeks
Emotional or psychological distress of carer
Neuropsychiatry Inventory Questionnaire will be used to assess the distress of caregivers. Caregiver distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by scores from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=very severe distress), giving a maximum score of 60.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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 DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daphne Sze Ki Cheung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104436
- Sponsor's protocol ID
- A0047147
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheung DSK, Tse JHY, Ho KHM, Macritchie J, Lai CKY, Buckwalter K, Wang S, Lee PH, Bressington D, Chan AHT, Ho GWK. Individualised Music Playlist Based on the Iso-Principle for De-Escalating Agitation in Older People With Dementia: Protocol for a RCT. Nurs Open. 2026 Jul;13(7):e70663. doi: 10.1002/nop2.70663.
PubMed 42400199
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Individualized Music Playlist Based on the ISOPrinciple for the Immediate De-escalation of Agitation in People With Dementia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06104436
- Acronym / sponsor ID
- A0047147
- Conditions
- Dementia
- Keywords
- Dementia, Agitation, Music
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2023 (actual)
- 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.
The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU).
Detailed description
- Study design
- Randomized controlled trial
- Participants
- Eighty-one older adults living with dementia and demonstrate significant agitation
- Setting:
- Residential care home
- Intervention
- Individualized music listening intervention played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.
- Comparison conditions
- Preferred music listening group: Preferred music listening played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.
- Usual care group: usual care
- Outcomes
- Level of agitation measured with the Pittsburgh Agitation Scale
- Intensity of agitation measured with the Positive and Negative Syndrome Scale - Excited Component
- Agitation occurrence frequency measured with Cohen-Mansfield Agitation Inventory
- Distress of formal caregivers related to agitation measured with Neuropsychiatric Inventory
- Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized music playlist | Experimental | Behavioral: Individualized music playlist, Behavioral: Usual careComposed of preferred music genres sequenced according to the ISO-Principle in addition to usual care. |
| Preferred music | Active comparator | Behavioral: Preferred music, Behavioral: Usual carePreferred music genres played in random sequence in addition to usual care. |
| Treatment as usual | Sham comparator | Behavioral: Usual careUsual care for agitation management. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- residents in long-term care facilities
- diagnosed with any type of dementia
- presented with significant agitation
Key exclusion criteria (4 listed)
- had been admitted to the facility for less than three months
- are participating in other studies or experimental therapies
- have a comorbid psychiatric illness
- have physical illness that prevents them from listening to music
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 |
|---|---|---|
| Individualized music playlistIndividualized music playlist composed of preferred music genres sequenced according to the ISO-Principle. It will be played at the state of agitation. | Behavioural | Individualized music playlist |
| Preferred musicPreferred music is composed of the genres selected by the participants, and to be played at random sequence. | Behavioural | Preferred music |
| Usual careUsual technique for calming agitated older adults with dementia | Behavioural | Individualized music playlist, Preferred music, Treatment as usual |
Primary outcome
Level of agitation
Time frame: 6 weeks
Positive and Negative Syndrome Scale - Excitatory Component will be used for assessing the level of agitation. It consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation.
Intensity of agitation
Time frame: 6 weeks
Pittsburgh Agitation Scale will be used to assess the intensity of agitation. It is a brief measure of agitation that measures the severity of agitation in four general categories: aberrant vocalisation, motor agitation, aggressiveness and resisting care, on a scale from 0 (not present) to 4 (highest level).
Agitation status
Time frame: 6 weeks
Behavioural Activity Rating Scale will be used to assess the agitation status. It contains a single-item question consisting of seven categories: 1=difficult or unable to rouse; 2=asleep, but responds normally to verbal or physical contact; 3=drowsy, appears sedated; 4=quiet and awake (normal level of activity); 5=signs of overt (physical or verbal) activity, calms down with instruction; 6=extremely or continuously active, not requiring restraint; 7=violent, requires restraint.
2 secondary outcomes
Agitation occurrence
Time frame: 6 weeks
Emotional or psychological distress of carer
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 42400199Cheung DSK, Tse JHY, Ho KHM, Macritchie J, Lai CKY, Buckwalter K, Wang S, Lee PH, Bressington D, Chan AHT, Ho GWK. Individualised Music Playlist Based on the Iso-Principle for De-Escalating Agitation in Older People With Dementia: Protocol for a RCT. Nurs Open. 2026 Jul;13(7):e70663. doi: 10.1002/nop2.70663.
- 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.
Daphne Sze Ki Cheung, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized music playlist and Preferred music in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 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: opening soon, as of the sponsor's last update on 28 Feb 2024. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphne Sze Ki Cheung, PhD (+852 27664534, daphne.cheung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of agitation (time frame: 6 weeks). The study lists 3 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 NCT06104436, 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 28 Feb 2024.