Clinical trial NCT01123993: The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia
Official title: The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cognitive Function
Sleep
Keywords: Thai traditional music
dementia
Cognitive function
behavioural problem
sleep quality
psychological health
quality of sleep
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Severe depression requiring aggressive treatment or hospitalization
* Dementia with Lewy body, multisystem atrophy
* Treatable dementia
* Active medical problems
* Profound hearing loss

Primary outcomes:
measure: Depression
timeFrame: 4-week after regularly listening to the music for 28 days
measure: Activities of Daily Living
timeFrame: 4-week after music
measure: Behavior
timeFrame: 4-week after music
measure: Sleep quality
timeFrame: 4-week after music
Secondary outcomes:
measure: reduction of the care giver's stress and burden
timeFrame: 4-week after intervention
Other outcomes:
Locations:
city: Rachatevee
country: Thailand
facility: Division of Neurology, Phramongkutklao Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital
Study officials:
affiliation: Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
name: Pasiri Sithinamsuwan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
name: Sansanee Saengwanitch, MD
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Thanawong Yongarnukul
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Tanuphat Tuan-iam
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Kanokporn Wonganankit
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Chananya Potisuk
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Sittichoke Sirimontakan
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Sariya Wongsangsak
role: STUDY_CHAIR
affiliation: Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
name: Akarachaid Pinidbunjerdkool, MD
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Mathirut Mungthin, MD
role: STUDY_DIRECTOR
References: