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

This study will recruit a total of 120 older adults who are permanent residents of the Woodlake Legacy Senior Living (Lakewood, CO) and Woodland Estates Senior Living (Denver, CO) facilities near Denver, Colorado, USA. Recruitment will take place among assisted living and memory care communities at the designated sites. Subjects and/or their legal guardian are required to provide written and informed consent prior to inclusion in the study, in accordance with the Declaration of Helsinki.

Before allocation in the study groups, subjects are screened on demographic and medical factors pertaining to the inclusion and exclusion criteria of the study. Severity of cognitive impairment will be tested using the Standardized Mini-Mental State Examination (S-MMSE). Each task is scored based on the individual's performance, with a maximum score of 30 points indicating normal cognitive function. The S-MMSE questions are asked orally and the particular questions involving writing, reading, and drawing are carried out on paper, with the total duration for each patient ranging from 30 to 40 min. S-MMSE is categorized into different levels of cognitive impairment. The scores 19-25 represent mild impairment, 10-18 indicate moderate impairment and scores below 10 signify severe impairment. Subjects will be asked to complete a customized music inventory questionnaire scoring their preference from the list of available music styles/genres. Based on the indicated preference, music playlist selection will be personalized for each subject.

Subjects are allocated to one of four groups that will receive the following interventions: (1) group B0S0: music playlist (control group); (2) group B1S0: BBM, music playlist; (3) group B0S1, SM, music playlist; (4) group B1S1: BBM + SM, music playlist.

At each of the two designated sites, a quiet room with comfortable seating is prepared to host up to 10 subjects at a time. Subjects in assisted living and memory care communities will be tested in separate rooms, located within a familiar area of their living facility, to avoid disruption of routine. Subjects are picked up at the scheduled time of their sessions, escorted to the test environment by the designated staff member, and returned after completing the music session.

After a group of subjects is seated, a tablet (Samsung A9 Android 15 11-inch Tablet, Gumi, South-Korea) and wireless noise-cancelling headphones (Sony WH-1000XM6, Minato, Tokyo, Japan) connected through Bluetooth (v5.4) are distributed to each subject. The subjects are assisted by the on-site investigators with starting the music playlist in their preferred style/genre from the tablet and adjusting the headphones to a prescribed standard playback volume, i.e., a sound pressure level of < 75 dB. It is suggested that subjects close their eyes while enjoying the music sessions. All subjects will listen to a ±20-minute session once a day for a total period of 14 consecutive days. AM sessions take place between 9-11 a.m. and PM sessions between 2-4 p.m. Groups are equally distributed between the AM and PM sessions to control for confounding effects across groups. In this way, bias of the time of day is avoided to interfere with the type of condition, e.g., BPSD in older adults with moderate to severe dementia in an assisted living facility was found to decrease more in the AM compared to the PM in response to a music intervention. Increased agitation behaviors during the late afternoon and evening is commonly referred to as 'sundowning'.