The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia

Sleep Clinical Trial

Official title:

The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123993
• Other study ID #: R006h/53
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2010
• Last updated: January 3, 2011
• Start date: February 2010
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Function
• Sleep

Intervention

Device:
• Music CD
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.

Locations

Country	Name	City	State
Thailand	Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital	Bangkok
Thailand	Division of Neurology, Phramongkutklao Hospital	Rachatevee	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Using Thai Geriatric Depression Scale (TGDS)	4-week after regularly listening to the music for 28 days	No
Primary	Activities of Daily Living	using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)	4-week after music	No
Primary	Behavior	Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)	4-week after music	No
Primary	Sleep quality	Using Pittsburgh Sleep Quality Index (PSQI)	4-week after music	No
Secondary	reduction of the care giver's stress and burden	Using visual analog scale	4-week after intervention	No