Effects of Binaural Beats and Spatialized Music on Behavioural and Psychological Symptoms of Dementia in Assisted Living Facility Residents

Part of paid clinical trials in Denver, Colorado.

Sponsor
Maharishi International University
Study ID
NCT07626944
Status
Recruiting
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Conditions

  • BPSD
  • Caregiver Distress
  • Mood
  • Well-being

Eligibility Criteria

Sex
ALL
Age
55 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized Music Listening (PML) — OTHER
    A personlized music playlist is generated by an audio workstation based on text prompts describing prominent musical features for a chosen favourite genre and style. For each entry in the music playlist, acoustic features are extracted from the audio waveforms and higher-level perceptual features are derived that correlate with human emotional and physiological responses to music. A music playlist with a total duration of ±20 minutes is generated for each individual session based on the derived higher-level perceptual features. The selection and slope of a music playlist is adjusted for the time of day by considering the progression of extracted audio features, i.e., an upward slope to increase arousal for morning sessions (AM) and a downward slope to induce a calming effect for afternoon sessions (PM). PML sessions are administered using wireless noise-cancelling headphones and take place in a quiet room with comfortable seating for groups of up to 10 subjects at a time.
  • Binaural Beat Music (BBM) — OTHER
    BBM is the combination of pure tones with a variable carrier frequency embedded in the music playlist recordings. The carrier frequency is adaptive to the music it is combined with. A fixed 10 Hz difference between the carrier frequencies of the left and right headphone channels produces a perceived binaural beat frequency corresponding to an alpha brain-wave pattern associated with relaxation.
  • Spatialized Music (SM) — OTHER
    SM is the presentation of the music playlist such that vocal and instrumental stems are perceived as reverberating within a virtual space from different angles and positions relative to the subject. The music recordings are modified and rendered as a spatialized version using acoustic simulation software.

Study Details

The purpose of this study is to investigate the effects of Binaural Beat Music (BBM; personalized music playlist with binaural beats), Spatialized Music (SM; personalized and spatialized music playlist), their combination, and possible interaction on older adults in an assisted living community who are either living with a dementia diagnosis or are experiencing typical age-related changes. The control condition is a personalized music playlist without binaural beats and spatialization. It is hypothesized that BBM, SM, and their combination each improve aspects of BPSD compared to controls over a two-week intervention period. The Specific Aims of the study are (1) to evaluate whether BBM, SM, and/or their combination is superior to control in reducing BPSD severity (primary outcome); (2) to evaluate whether BBM, SM, and/or their combination is superior to control in reducing caregiver distress (secondary outcomes); and (3) to evaluate the effects of BBM, SM, and/or their combination on improving overall well-being and mood (secondary outcomes).

Key Dates

Start date
May 4, 2026
Status verified
May 2026
Primary completion
Jun 27, 2026
Completion
Jun 27, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: B0S0
    Music playlist (control)
  • Active Comparator: B1S0
    Binaural Beat Music, Music Playlist
  • Active Comparator: B0S1
    Spatialized Music, Music Playlist
  • Active Comparator: B1S1
    Binaural Beat Music, Spatialized Music, Music Playlist

Primary Outcome Measure

BPSD Severity - assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Before the start and after completion of a 2 week treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIP
Woodland Estates Senior LivingDenverColorado80231
Woodlake Legacy Senior LivingLakewoodColorado80228

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Woodland Estates Senior Living· Denver, COWoodlake Legacy Senior Living· Lakewood, CO

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