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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-95
SponsorMaharishi International University

About this trial

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 criteria

Qualifiers

(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.

Disqualifiers

(1) profound hearing loss or impairment; (2) history of seizures, epilepsy (especially sound-induced epilepsy), claustrophobia, or other conditions that put the subject at risk during the trial; (3) physical or mental conditions that may result in inability to complete and/or affect the efficacy of assessment.

Trial design

Treatments tested in this trial

  • Personalized Music Listening (PML)
  • Binaural Beat Music (BBM)
  • Spatialized Music (SM)

Treatment groups

120 Participants
are divided into 4 treatment groups

Locations

2
Woodland Estates Senior Living80231, DenverColorado, United States
Woodlake Legacy Senior Living80228, LakewoodColorado, United States

Sponsors and collaborators

Maharishi International University

Lead sponsor

Music in the Space Between LLC

Collaborator

CoroHealth LLC

Collaborator

Hollie Kemp Consulting LLC

Collaborator

Oxford Health Group LLC

Collaborator