Effects of Binaural Beat Music on Elderly Sleep
Examining the Effects of Binaural Beat Music on Sleep Quality, Heart Rate Variability, and Depression in Older People With Poor Sleep Quality in a Long-term Care Institution: A Randomized Controlled Trial
1 other identifier
interventional
64
1 country
1
Brief Summary
Background: Older people in long-term care institutions often have poor sleep quality and depression, which may negatively affect their health and welfare. Binaural beat music (BBM) has been proposed as a possible intervention. However, its effects on older people with poor sleep quality in long-term care institutions is still unclear. Objective: This study aimed to examine the effects of binaural beat music on sleep quality, heart rate variability, and depression in older people with poor sleep quality in a long-term care institution Methods: A single-blind randomized controlled trial design was employed and 64 older participants with poor sleep quality were recruited from a long-term care institution in Taiwan. Participants were randomized into the BBM group or control (sham) group (32 per group) and received 14 days of intervention. During the intervention period, participants in the experimental group listened to 20 minutes of Taiwanese Hokkien oldies embedded with BBM once in the morning and afternoon thrice a week. Participants in the control group only listened to Taiwanese Hokkien oldies. Questionnaires and heart rate variability analysis were used to assess participants' sleep quality, heart rate variability, and depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 27, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedAugust 4, 2023
July 1, 2023
7 months
July 27, 2023
July 27, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
There were 18 questions in the PSQI, and participants used a self-rated method to fill in their sleep quality in the last month on a 4-point Likert scale. The total score range was 0-21 points. The higher the score, the poorer the sleep quality. This scale has seven dimensions, including: (1) Subjective sleep quality; (2) Sleep latency; (3) Sleep duration; (4) Sleep efficiency; (5) Sleep disturbances; (6) Daytime dysfunction; and (7) Use of sleep medication. PSQI had good validity and reliability(Tsai et al., 2005).
On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 10 minutes.
HRV analyzer
HRV was used to measure heart rate variability, including five markers: (1) Mean heart rate; (2) SDNN: Standard deviation of all RR intervals, represent the physiological health of autonomic nervous system; the higher the SDNN, the better the physiological health of the autonomic nervous system; (3) nLF: Normalized low frequency, reflects sympathetic nervous activity. The higher the value, the greater the activity; (4) nHF: Normalized high frequency, reflects parasympathetic nervous activity. The higher the value, the greater the activity; (5) LF/HF, a marker reflecting sympathetic and parasympathetic nervous activity.
On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes
Secondary Outcomes (1)
Geriatric Depression Scale (GDS)
On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes
Study Arms (2)
Binaural beat music group (BBM group)
EXPERIMENTAL20 minutes of music thrice a week (Monday, Wednesday, and Friday) for two weeks (total of 12 times)
Control group
SHAM COMPARATOR20 minutes of music thrice a week (Monday, Wednesday, and Friday) for two weeks (total of 12 times)
Interventions
The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) with BBM embedded.
The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) without BBM embedded.
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (1)
Asia Univeraity
Taichung, WuFeng, 41354, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
July 27, 2023
First Posted
August 4, 2023
Study Start
September 1, 2022
Primary Completion
March 30, 2023
Study Completion
July 1, 2023
Last Updated
August 4, 2023
Record last verified: 2023-07