Clinical trial NCT05975853: Effects of Binaural Beat Music on Elderly Sleep
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 64
Sex: ALL
Minimum age (years): 75
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were participants who: were aged 65 years and older, had a PSQI score\> 7, were able to understand questionnaire contents and communicate in Mandarin or Taiwanese Hokkien, stayed in institution for 1 month and more, and did not receive antidepressant within 3 months prior to and during the intervention.

Exclusion Criteria:

* Exclusion criteria were those with hearing loss, history of bipolar disorder or schizophrenia diagnosed by a physician, and had an acute physiological disease, such as cold, fracture, or trauma.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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.
measure: HRV analyzer
timeFrame: 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:
measure: Geriatric Depression Scale (GDS)
timeFrame: 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
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia Univeraity
state: WuFeng
Study officials:
References: