Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChina Medical University, China
About this trial
This study will evaluate whether binaural beats can improve cognitive function in older adults with mild cognitive impairment living in nursing homes. Participants will listen to 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. Cognitive function, sleep quality, anxiety, and depressive symptoms will be assessed before the intervention, after the intervention, and at a 2-week follow-up after the intervention. The study aims to determine whether binaural beats are a safe, simple, and non-drug approach to support cognitive health in older adults with mild cognitive impairment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 years or older.
Not previously diagnosed with dementia.
Meets the diagnostic criteria for mild cognitive impairment, with Montreal Cognitive Assessment scores adjusted by education level, Mini-Mental State Examination score >= 24, and Activities of Daily Living score < 23.
Has lived in a nursing home for more than 2 months and plans to continue living there during the study period.
Disqualifiers
Severe physical disease, major organ failure, or advanced malignant tumor.
Diagnosed depression or other psychiatric disorders.
Serious adverse events during the study, such as falls, disease recurrence, discomfort caused by the intervention audio, death, or other conditions making continued participation unsuitable.
Voluntary withdrawal from the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Binaural Beats Embedded in Old Songs
BehavioralParticipants in the intervention group will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences.
Old Songs
BehavioralParticipants in the control group will listen to old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Binaural Beats Plus Old Songs GroupExperimental treatment 1 intervention
Group B: Old Songs GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Montreal Cognitive Assessment Score
Cognitive function will be assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention2
Change in Digit Span Test Score
Time frame
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention3
Change in Stroop Color-Word Test Score
Time frame
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention4
Change in Trail Making Test Score
Time frame
Baseline, immediately after the 14-day intervention, and 2 weeks after the interventionSponsors and contacts
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Source ClinicalTrials.gov