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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Well-being; Mood; BPSD; Caregiver Distress
• Intervention / Treatment: Other: Personalized Music Listening (PML); Other: Binaural Beat Music (BBM); Other: Spatialized Music (SM)

Detailed Description

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'.

Demographic and medical information of each subject will be collected from the web-based patient administration system (augusthealth.com) used at the designated sites, prior to allocation of the subject to the study groups. Outcome measures pre- and post-sessions will be collected using tablets operated by the on-site investigators and administered via a web-based patient administration system that includes the designated assessment instruments (sagelyweb.com). The accessible population at the designated sites is familiar with the data-collection procedure for this system. This provides for consistency across collection, analysis and reporting of the data at study completion.

Compliance with the testing and treatment protocols is warranted by the on-site investigators who schedule and guide the music sessions with the subjects. The designated staff members will follow up with reminders about the scheduled sessions and physically assist the subjects to and from the test environment at the appointed times. Progress of the enrollment, allocation of the interventions and testing will be monitored throughout the duration of the study according to the Consolidated Standards of Reporting Trials (CONSORT).

If one of the conditions occurs as following, the follow-up will be discontinued: (1) serious adverse reactions during the trial; (2) the subject and/or designated staff member and/or his/her family members request to terminate or withdrawal; (3) the subject's condition changes, and the physician in charge judges that treatment should be terminated; (4) behaviour that violates legitimacy of the trial.

The choice of measurement instruments and administration frequency was guided by two principles: (1) To assess as broad a spectrum as possible of behavioral and emotional disturbances that are considered to be of greatest concern among assisted living facility administrators and staff; and (2) to collect samples sufficiently often to allow detection of any time-varying changes.

Daily dependent measures include Emoji Mood Scales (EMS) are administered before and immediately after each music session (pre and post-session). Baseline & Post-Intervention measures include the Neuropsychiatric Inventory Questionnaire (NPI-Q) and the WHO-5 Well-Being Index, and are administered ±3 days before the intervention period (baseline) and ±3 days after completion of the intervention period (post-intervention).

Adverse events of the interventions will be focused on, including registering side effects currently unknown. Although no adverse effects of BBM and SM have been previously reported, if there are new side effects associated with BBM and/or SM in this trial, they will be recorded. In the event of a serious adverse event, the study will be discontinued to break the blind, corresponding treatment measures will be taken to protect the safety of the subjects, and the event will be reported to the IRB.

Demographic information and outcome measures pertaining to the subjects as recorded by the investigators in the patient registration system will be anonymized before data processing and statistical analysis. The investigators responsible for data analysis will perform an intention-to-treat (ITT) analysis of the collected data using IBM SPSS (version 31). Data will be presented according to their statistical features and distribution. All continuous variables are expressed as mean and standard deviation, and categorical variables are expressed as counts and percentages. Between-group Chi-square tests, Fisher's exact tests, or nonparametric tests will be used to analyze categorical data. Analysis of variance or nonparametric tests will be used for analyzing continuous data.

The summed scores for each instrument for each participant will be assessed pre against post-session and post-intervention against baseline to model and analyze variance. Outcomes shall be evaluated using between-group comparisons of post-intervention scores against baseline. Stratification of between-groups differences will be explored by (1) diagnostic groups, i.e., assisted living or memory care; (2) time of day, i.e., AM or PM; and (3) gender. Two-tailed p-values less than 0.05 will be considered statistically significant. Effect sizes will be calculated using standardized mean differences (SMD), i.e., the difference in mean change between groups divided by the pooled standard deviation using Hedge's g with a correction factor for small study sample (n < 50 per group).

We will perform additional multivariable regression analyses to identify potential trends and correlations and adjust for potential confounders, including (1) baseline dependent measure; (2) music preference score; (3) cognitive function; (4) ethnicity; and (5) medication (yes/no) as covariates. For secondary analyses, a Bonferroni correction will be applied to adjust for multiple comparisons with adjusted p-values.

We expect to find a statistically meaningful improvement from baseline in BPSD severity in at least one intervention group (B1S0, B0S1, and/or B1S1) compared to the control group (B0S0) or a moderate effect size in at least one intervention group compared to control. Similar findings are expected in terms of the secondary outcomes, i.e., caregiver distress, subjective well-being, and mood. If the expected results are confirmed, BBM and/or SM may be seen as a viable, non-invasive treatment for decreasing BPSD symptoms in dementia patients, as well as for reducing the onset of symptoms of MCI in older adults who are experiencing typical age-related changes. The associated benefits of the intervention may increase caregiver relief and subjective experience of well-being and mood in older adults in senior living communities.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Oomen, MMus; Phone Number: +36203980356; Email: poomen@nemolabs.info

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80231
      • Recruiting
      • Woodland Estates Senior Living
      • Contact: Anthony Geiser; Phone Number: 303-671-2500; Email: admin@woodlandsl.com
      • Principal Investigator: Hollie Kemp
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • Woodlake Legacy Senior Living
      • Principal Investigator: Hollie Kemp
      • Contact: Matthew Wistreich; Phone Number: 224 303-237-5700; Email: admin@woodlakesl.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: B0S0; Music playlist (control)	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.
Active Comparator: B1S0; Binaural Beat Music, Music Playlist	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.
Active Comparator: B0S1; Spatialized Music, Music Playlist	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: 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.
Active Comparator: B1S1; Binaural Beat Music, Spatialized Music, Music Playlist	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before the start and after completion of a 2 week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before the start and after completion of a 2 week treatment
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.	Before the start and after completion of a 2 week treatment
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.	Before and after each 20 minute music sessions, for 14 days consecutively.

Collaborators and Investigators

• Sponsor: Maharishi International University
• Collaborators: Music in the Space Between LLC; CoroHealth LLC; Hollie Kemp Consulting LLC; Oxford Health Group LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): June 27, 2026

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dementia; Randomized Controlled Trial; Artificial Intelligence; Well-being; Mood; Binaural Beat Stimulation; Caregiver Distress; Personalized Music Listening; Spatial Audio; Assisted Living Residences
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: MIU-CPHS-01-04-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No