Actively Recruiting
Effects of Binaural Beats and Spatialized Music on Behavioural and Psychological Symptoms of Dementia in Assisted Living Facility Residents: A Randomized Controlled Pilot Protocol
Led by Maharishi International University · Updated on 2026-06-04
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Maharishi International University
Lead Sponsor
M
Music in the Space Between LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of Binaural Beat Music (BBM), Spatialized Music (SM), their combination, and a control personalized music playlist on older adults living in assisted living communities who have dementia or age-related cognitive changes. The study aims to see if these music interventions reduce behavioral and psychological symptoms of dementia (BPSD), caregiver distress, and improve well-being and mood over a two-week period. Participants will be randomly assigned to one of four groups: control music playlist, BBM with music playlist, SM with music playlist, or a combination of BBM and SM with music playlist. Each participant will listen to a personalized 20-minute music session daily for 14 consecutive days, either in the morning or afternoon, using wireless noise-cancelling headphones in a quiet, comfortable room. Throughout the study, participants will complete cognitive tests and mood assessments before and after sessions, including the Neuropsychiatric Inventory Questionnaire (NPI-Q), Emoji Mood Scales (EMS), and WHO-5 Well-Being Index. Staff will assist participants with sessions, and data on symptoms, mood, and caregiver distress will be collected and analyzed. Safety and adherence will be monitored, and the total participation lasts for the two-week intervention with assessments before and after this period.
CONDITIONS
Brief Title
Effects of Binaural Beats and Spatialized Music on Behavioural and Psychological Symptoms of Dementia in Assisted Living Facility Residents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 55 and 95 years
- Signed written informed consent by the subject and/or legal guardian
- Ability to complete the entire trial period
- At least 50% of participants with moderate to severe dementia diagnosis
You will not qualify if you...
- Profound hearing loss or impairment
- History of seizures, epilepsy (especially sound-induced epilepsy), or claustrophobia
- Physical or mental conditions that may prevent completion or affect assessment efficacy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 consecutive days
Participants listen to personalized music playlists with or without binaural beat music and spatialized music sessions.
Daily sessions lasting approximately 20 minutes each
Duration - Approximately 6 days (±3 days before and after treatment)
Participants complete assessments to evaluate behavioral and psychological symptoms, caregiver distress, well-being, and mood before and after the treatment period.
2 visits (baseline and post-intervention assessments)
Trial Site Locations
Total: 2 locations
1
Woodland Estates Senior Living
Denver, Colorado, United States, 80231
Actively Recruiting
2
Woodlake Legacy Senior Living
Lakewood, Colorado, United States, 80228
Actively Recruiting
Research Team
P
Paul Oomen, MMus
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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