UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054975 |
|---|---|
| Receipt number | R000062794 |
| Scientific Title | Research on Passive Music Therapy for coping BSPD Symptoms in the Elderly |
| Date of disclosure of the study information | 2024/07/26 |
| Last modified on | 2024/07/27 11:06:40 |
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Basic information
Public title
Study on Passive Music Therapy Aimed at Improving Behavioral and Neurological Symptoms in the Elderly
Acronym
Passive Music Therapy
Scientific Title
Research on Passive Music Therapy for coping BSPD Symptoms in the Elderly
Scientific Title:Acronym
Music Therapy for coping BPSD
Region
| Japan |
Condition
Condition
Elderly dementia patients
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to implement passive music therapy using music devices for subjects with BPSD symptoms in dementia patients, delirium symptoms in the elderly, and sleep disorders. By employing highly sensitive sleep analysis devices used as a global standard and validated scales, the study examines the usefulness of non-pharmacological treatments. The goal is to improve the quality of life (QOL) of patients and reduce the burden on exhausted caregivers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSQI (Pittsburgh Sleep Quality Index), NPI (Neuropsychiatric Inventory) scores, sleep efficiency, number of naps, etc.
Key secondary outcomes
MMSE (Mini-Mental State Examination), SODA (Sleep Orientation Activity Demand), delirium score, living conditions survey, etc. are used as indicators.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
passive music therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with dementia who also have sleep disorders, or elderly individuals without dementia who have sleep disorders such as BPSD-like symptoms or delirium. Additionally, those considered to have sleep disorders include individuals who feel they have sleep issues, either personally or through their caregiver's observation, or those who have been diagnosed with conditions like insomnia by a doctor
Key exclusion criteria
Elderly individuals without BPSD symptoms and elderly individuals without sleep disorders.
Patients with severe hearing loss (completely deaf), those without caregivers, and those who strongly refuse the test contents of this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | IZUMISAWA |
Organization
Nihon University
Division name
College of Pharmacy
Zip code
274-8555
Address
7-7-1 Narashinodai Funabashi-shi
TEL
0474657413
izumisawa.megumi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | IZUMISAWA |
Organization
Nihon University
Division name
College of Pharmacy
Zip code
2748555
Address
7-7-1 Narashinodai Funabashi-shi
TEL
0474657413
Homepage URL
izumisawa.megumi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Megumi IZUMISAWA
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
College of Pharmacy Nihon University
Address
7-7-1 Narashinodai Funabashi-shi
Tel
0474652111
pha.res-staff@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
介護老人保健施設ひまわり水戸
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.c-linkage.co.jp/jssr46/files/program3.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.c-linkage.co.jp/jssr46/files/program3.pdf
Number of participants that the trial has enrolled
7
Results
The clinical symptoms of patients and caregivers were measured by the NPI_NH score to confirm the effects of this music therapy on BPSD symptoms and other symptoms. As a result, not only did the subject's mind become more stable and BPSD symptoms with strong problematic behaviors were reduced, but also sleep onset disorder, mid-wakefulness, and other symptoms showed a tendency to improve. On the other hand, improvement of agitation was low, and insomnia showed a low tendency to improve.
Results date posted
| 2024 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 23 | Day |
Baseline Characteristics
Elderly patients admitted to a geriatric long term care health facility.
Patients had BPSD-like complaints and insomnia symptoms either difficulty falling asleep, awakening in the middle of the night, or difficulty sleeping soundly
Participants 2 males and 5 females)2 males and 5 females.
The group with insomnia was 87 years old, and the group without insomnia was 89 years old.
Participant flow
Elderly patients admitted to a geriatric long-term care health care facility who present with BPSD-like complaints and insomnia symptoms (e.g., difficulty falling asleep, awakening mid-morning, difficulty sleeping soundly, etc.)
Adverse events
None
Outcome measures
Primary endpointb NPI-NH score on the BPSD scale
Secondary endpoints Number of naps and other sleep conditions, and special notes on daily life observation
Plan to share IPD
No plan
IPD sharing Plan description
None
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062794
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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