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Effects of Binaural Beats and Spatialized Music on Behavioural and Psychological Symptoms of Dementia in Assisted Living Facility Residents: A Randomized Controlled Pilot Protocol

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 95
Healthy Volunteers: f
View:

• (1) age 55-95 years; (2) the subject and/or his/her legal guardian have signed written informed consent; (3) the subject is able to complete the entire trial period; and (4) a minimum of fifty percent of the subjects will have a diagnosis of a dementia condition with a moderate to severe progression.

Locations
United States
Colorado
Woodland Estates Senior Living
RECRUITING
Denver
Woodlake Legacy Senior Living
RECRUITING
Lakewood
Contact Information
Primary
Paul Oomen, MMus
poomen@nemolabs.info
+36203980356
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2026-06-27
Participants
Target number of participants: 120
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Oxford Health Group LLC, Music in the Space Between LLC, CoroHealth LLC, Hollie Kemp Consulting LLC
Leads: Maharishi International University

This content was sourced from clinicaltrials.gov