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).
(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.
(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.
Factorial
Personalized Music Listening (PML)
Other interventionA 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 interventionBBM 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 interventionSM 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.
BPSD Severity - assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI-Q is consists of a 12-item questionnaire and assesses a broad range of psychiatric disturbances associated with: (1) delusions; (2) hallucinations; (3) agitation or aggression; (4) depression or dysphoria; (5) anxiety; (6) elation or euphoria; (7) apathy or indifference; (8) disinhibition; (9) irritability or lability; (10) motor disturbance; (11) nighttime behaviors; and (12) appetite and eating. Each item is scored whether it is present, and if so, how severe it is on a 3-point scale. Total scores as well as item scores are assessed. A reduction of 3 or more points on the total score indicated clionically meaningful improvement.
Caregiver Distress - assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI-Q assesses the distress to the caregiver on a 6-point scale for each item. To the extent that the interventions are effective in relieving behavioral and emotional problems in patients, these changes may in turn affect the well-being of their caregivers.
Subjective Well-being - assessed by the WHO-5
The 5-item World Health Organization Well-Being Index (WHO-5) is used assessing subjective psychological well-being. A raw score from 0 to 25 is multiplied by 4 to create a 0-100 score, where higher scores indicate better well-being. A score of 50 or below indicates poor mental well-being and suggests the need for further evaluation. A score of 28 or below strongly indicates likely depression. A clinically relevant change in the WHO-5 Well-Being Index is generally defined as a 10-point difference (or more) on the 0-100 scale. This shift reliably indicates that an individual's psychological well-being has meaningfully improved or deteriorated.
Subjective Mood - assessed by Emoji Mood Scales (EMS)
EMS is a validated, ultra-brief measure of mood and current experience, with minimal literacy demands on participants. For this study, we administer an emoji-ordinal scale with 3 categories: (1) unhappy emoji: frowning face (unicode U+2639); (2) neutral emoji: neutral face (U+1F610); and (3) happy emoji: smiling face (U+1F642). In addition to EMS measures, investigators will note any comments, phrases, and vocalizations from the subject.
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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
