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

NCT07626944 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-04

No results posted yet for this study

Summary

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).

Conditions

  • BPSD
  • Caregiver Distress
  • Well-being
  • Mood

Interventions

OTHER

Personalized Music Listening (PML)

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.

OTHER

Binaural Beat Music (BBM)

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.

OTHER

Spatialized Music (SM)

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.

Sponsors & Collaborators

  • Music in the Space Between LLC

    collaborator UNKNOWN
  • CoroHealth LLC

    collaborator UNKNOWN
  • Hollie Kemp Consulting LLC

    collaborator UNKNOWN
  • Oxford Health Group LLC

    collaborator UNKNOWN
  • Maharishi International University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-04
Primary Completion
2026-06-27
Completion
2026-06-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626944 on ClinicalTrials.gov