Cognitive FunctionPhase 3NCT01123993
The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia
A Phase 3 study testing Music CD in people with Cognitive Function and Sleep, run by Phramongkutklao College of Medicine and Hospital at 2 sites in Thailand.
Trial summary
To determine the effect of Thai traditional music on cognitive function, psychological health and quality of sleep among Thai older individuals with dementia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Function, Sleep
- What is being tested?
- Music CD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesThailand
- Study dates
- Feb 2010to Sep 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 years
- Diagnosed with Alzheimer's disease, vascular dementia or mixed dementia by ICD-10
- No change in neuropsychiatric drugs for at least 4-week before and 8-week during the study
- CD player available at home
- Patient and care giver consent to study
Who cannot join
- Severe depression requiring aggressive treatment or hospitalization
- Dementia with Lewy body, multisystem atrophy
- Treatable dementia
- Active medical problems
- Profound hearing loss
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital
Bangkok, Bangkok, 10400
Division of Neurology, Phramongkutklao Hospital
Rachatevee, Bangkok, 10400
About this study
Official title: The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia.
To determine the effect of Thai traditional music on cognitive function, psychological health and quality of sleep among Thai older individuals with dementia.
Read the detailed description
Dementia, regardless of its cause, has been recognized to be one of the most important and common problems among the elderly worldwide. The prevalence of dementia has been increasing gradually throughout the world. It is associated with medical and psychological consequences, especially in the advanced stage of the condition. Medications for dementia, specifically, acetylcholine esterase inhibitors, have proven efficacy but variable individual response. They are very expensive and stress families and insurance payers. Dementia and its neuropsychiatric co-morbidities effects not only individual patients, but also family members and care givers as it stresses interpersonal relationships, increases the need for personal care, nursing home placement, and the use of neuropsychiatric medications. Any new approach to improve cognitive function, behavior, mood and sleep quality among demented individuals therefore could have far reaching benefits for patients, care givers, financially responsive parties, and the country as a whole.
There are several studies focusing on the non-pharmacologic approaches to care of the demented. The objectives were to reduce reliance on prescribed medications with these adjunctive therapies. One of the interesting non-drug trials was about music therapy. It was found that music could improve behavioral and social functions among individual demented patients. However, the methodology of each music study varied considerably. To our knowledge, there has been no music study in dementia performed in Thailand using our unique Thai traditional music. We therefore aim to study this non-pharmacologic approach in Thai demented individuals using Thai traditional music. We hypothesized that regular listening to Thai traditional music will improve cognitive function, activities of daily living, mood, behavior and sleep quality in Thai demented patients.
- Conditions
- Cognitive Function, Sleep
- Being tested
- Music CD
- Keywords
- Thai traditional music, dementia, Cognitive function, behavioural problem, sleep quality, psychological health, quality of sleep
- Medical subject headings
- Dementia, Mental Disorders, Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music CDDevice
During 4-week interventional period of each group, a researcher gives a CD to care giver and advises him/her to open the music for patient for at least 60 minutes daily, after dinner to bedtime. Meanwhile, the care giver notes the exact duration that patient actually listens to it in the calendar provided and returns the CD and document to the researcher at the end of interventional period.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counselling | No intervention | Not described Receives: Device: Music CD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Using Thai Geriatric Depression Scale (TGDS)
Measured: 4-week after regularly listening to the music for 28 days
Activities of Daily Living
using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)
Measured: 4-week after music
Behavior
Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)
Measured: 4-week after music
Sleep quality
Using Pittsburgh Sleep Quality Index (PSQI)
Measured: 4-week after music
Secondary outcomes (1)
reduction of the care giver's stress and burden
Using visual analog scale
Measured: 4-week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Pasiri Sithinamsuwan, MD, Principal investigator, Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, ThailandSansanee Saengwanitch, MD, Study chair, Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, ThailandThanawong Yongarnukul, Study chair, Phramongkutklao College of MedicineTanuphat Tuan-iam, Study chair, Phramongkutklao College of MedicineKanokporn Wonganankit, Study chair, Phramongkutklao College of MedicineChananya Potisuk, Study chair, Phramongkutklao College of MedicineSittichoke Sirimontakan, Study chair, Phramongkutklao College of MedicineSariya Wongsangsak, Study chair, Phramongkutklao College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123993
- Sponsor's protocol ID
- R006h/53
- Status last verified
- Jan 2011
- First submitted
- 2 May 2010
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia.
- ClinicalTrials.gov ID
- NCT01123993
- Acronym / sponsor ID
- R006h/53
- Conditions
- Cognitive Function, Sleep
- Keywords
- Thai traditional music, dementia, Cognitive function, behavioural problem, sleep quality, psychological health, quality of sleep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 May 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.
To determine the effect of Thai traditional music on cognitive function, psychological health and quality of sleep among Thai older individuals with dementia.
Detailed description
Dementia, regardless of its cause, has been recognized to be one of the most important and common problems among the elderly worldwide. The prevalence of dementia has been increasing gradually throughout the world. It is associated with medical and psychological consequences, especially in the advanced stage of the condition. Medications for dementia, specifically, acetylcholine esterase inhibitors, have proven efficacy but variable individual response. They are very expensive and stress families and insurance payers. Dementia and its neuropsychiatric co-morbidities effects not only individual patients, but also family members and care givers as it stresses interpersonal relationships, increases the need for personal care, nursing home placement, and the use of neuropsychiatric medications. Any new approach to improve cognitive function, behavior, mood and sleep quality among demented individuals therefore could have far reaching benefits for patients, care givers, financially responsive parties, and the country as a whole.
There are several studies focusing on the non-pharmacologic approaches to care of the demented. The objectives were to reduce reliance on prescribed medications with these adjunctive therapies. One of the interesting non-drug trials was about music therapy. It was found that music could improve behavioral and social functions among individual demented patients. However, the methodology of each music study varied considerably. To our knowledge, there has been no music study in dementia performed in Thailand using our unique Thai traditional music. We therefore aim to study this non-pharmacologic approach in Thai demented individuals using Thai traditional music. We hypothesized that regular listening to Thai traditional music will improve cognitive function, activities of daily living, mood, behavior and sleep quality in Thai demented patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counselling | No intervention | Device: Music CD |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 60 years
- Diagnosed with Alzheimer's disease, vascular dementia or mixed dementia by ICD-10
- No change in neuropsychiatric drugs for at least 4-week before and 8-week during the study
- CD player available at home
- Patient and care giver consent to study
Key exclusion criteria (5 listed)
- Severe depression requiring aggressive treatment or hospitalization
- Dementia with Lewy body, multisystem atrophy
- Treatable dementia
- Active medical problems
- Profound hearing loss
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 |
|---|---|---|
| Music CDDuring 4-week interventional period of each group, a researcher gives a CD to care giver and advises him/her to open the music for patient for at least 60 minutes daily, after dinner to bedtime. Meanwhile, the care giver notes the exact duration that patient actually listens to it in the calendar provided and returns the CD and document to the researcher at the end of interventional period. | Device | Lifestyle counselling |
Primary outcome
Depression
Time frame: 4-week after regularly listening to the music for 28 days
Using Thai Geriatric Depression Scale (TGDS)
Activities of Daily Living
Time frame: 4-week after music
using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)
Behavior
Time frame: 4-week after music
Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)
Sleep quality
Time frame: 4-week after music
Using Pittsburgh Sleep Quality Index (PSQI)
1 secondary outcome
reduction of the care giver's stress and burden
Time frame: 4-week after intervention
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 5 Jan 2011.
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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.
Pasiri Sithinamsuwan, MD principal investigator
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Sansanee Saengwanitch, MD study chair
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Thanawong Yongarnukul study chair
Phramongkutklao College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Music CD in people with Cognitive Function and Sleep, run by Phramongkutklao College of Medicine and Hospital at 2 sites in Thailand.
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 5 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 5 Jan 2011. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depression (time frame: 4-week after regularly listening to the music for 28 days). The study lists 4 primary outcomes in all. 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 5 Jan 2011.