Mixed Music Intervention on Sleep Disturbance in Patients With Parkinson's Disease

NCT05489653 | Terminated

• 1 other identifier: N202204014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease is a disease that is prevalent in the elderly, and the risk increases with age. Sleep disturbance is a common complaint of patients with Parkinson's disease, with a prevalence of 60% to 96%. Long-term sleep disturbance in Parkinson's disease patients significantly reduces cognitive function and quality of life. Nursing staff are the first line of care and should seek appropriate strategies to address sleep disturbances in patients with Parkinson's disease. This study is a feasibility and pilot study, which will be a single-blind, parallel randomized controlled trial. It is expected to include 30 patients with Parkinson's disease with poor sleep quality, and they will be equally allocated to the mixed music group (10 people), passive music group (10 people), and usual care group (10 people) in a 1:1:1 ratio. If assigned to the passive music group, they are required to listen to soft and low-pitched music at about 60 beats per minute for 30 minutes before sleep every day for four weeks. If assigned to the mixed music group, in order to synchronize active daytime music and passive music at bedtime, active daytime music will require patients to perform physical music activities once a week and watch a recorded music intervention video three times a week during the study period (The content is the same as the physical music activities) and follow the activities, and the intervention content before going to bed is the same as the intervention content of the pure passive music group. Subjects assigned to the usual care group maintained their original lifestyle and were assisted by study evaluators to complete pre-and post-test data. The researchers will establish a line group, and the three groups of patients or primary caregivers will be contacted by line every two days to care for the patient's condition. The variables measured included anxiety, depression, quality of life, and sleep quality, as assessed by the Hospital Anxiety and Depression Scale, Parkinson 's Disease. Questionnaire - 39, and the Pittsburgh Sleep Quality Scale . This study will use one-way ANOVA and linear mixed model for statistical analysis to test the hypothesis of this study. If the effectiveness of this intervention can be confirmed, it will be implemented in Parkinson's disease patients in the future to reduce sleep disturbances and improve patients' quality of life.

Conditions

Music Intervention; Sleep Disturbance; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index

  Sleep quality will be assessed by the Chinese version of the Pittsburgh Sleep Quality Scale, which is divided into subjective sleep quality, sleep quality and sleep quality. Lag period, total sleep hours, habitual sleep efficiency, sleep disturbance, sleep medication use, and daytime functional status. The total Pittsburgh sleep quality index is the total score of the seven major parts, so the total score is up to 21 points. If the total score is more than 5 points, it means sleep The quality is not good; on the contrary, the total score is ≤ 5 points, which means the sleep quality is good. Chinese version of Pittsburgh Sleep Quality Scale Internal Consistency (Cronbach's alpha) ranged from 0.82 to 0.83, with a sensitivity and specificity of 98% and 55%. Therefore, the scale is an accurate and reliable assessment tool.

  four-week intervention

Study Arms (3)

mixed music group

EXPERIMENTAL

If assigned to the mixed music group, in order to synchronize active daytime music and passive music at bedtime, active daytime music will require patients to perform physical music activities once a week and watch a recorded music intervention video three times a week during the study period (The content is the same as the physical music activities) and follow the activities, and the intervention content before going to bed is the same as the intervention content of the pure passive music group.

Behavioral: mixed music

pure passive music group

ACTIVE COMPARATOR

If assigned to the pure passive music group, they are required to listen to soft and low-pitched music at about 60 beats per minute 30 minutes before bed every day for four weeks.

Behavioral: mixed music

conventional treatment

NO INTERVENTION

Conventional treatment group maintained their original lifestyle and were post-tested with the assistance of a single-blind study evaluator.

Interventions

mixed music BEHAVIORAL

Learn about the effects of listening to music and doing activities with it on sleep.

mixed music group; pure passive music group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The test subjects must be adults or elderly aged 30 to 80 years old, with clear consciousness (Glasgow Coma Scale score 15), no obvious hearing impairment, diagnosed with Parkinson's disease in the first to third stages, Pittsburgh sleep quality expression is more than 5 points, has the ability to move independently with assistance,can communicate in Chinese or Taiwanese, and usually be accompanied by the main caregiver or family members.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Parasomnias; Parkinson Disease

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: November 10, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)