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

NCT07626944 | Recruiting

• 1 other identifier: MIU-CPHS-01-04-2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

BPSD; Caregiver Distress; Well-being; Mood

Keywords

Dementia; Well-being; Mood; Caregiver Distress; Personalized Music Listening; Binaural Beat Stimulation; Spatial Audio; Artificial Intelligence; Randomized Controlled Trial; Assisted Living Residences

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Caregiver Distress - assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

  Before the start and after completion of a 2 week treatment

• Subjective Well-being - assessed by the WHO-5

  Before the start and after completion of a 2 week treatment

• Subjective Mood - assessed by Emoji Mood Scales (EMS)

  Before and after each 20 minute music sessions, for 14 days consecutively.

Study Arms (4)

B0S0

SHAM COMPARATOR

Music playlist (control)

Other: Personalized Music Listening (PML)

B1S0

ACTIVE COMPARATOR

Binaural Beat Music, Music Playlist

Other: Personalized Music Listening (PML); Other: Binaural Beat Music (BBM)

B0S1

ACTIVE COMPARATOR

Spatialized Music, Music Playlist

Other: Personalized Music Listening (PML); Other: Spatialized Music (SM)

B1S1

ACTIVE COMPARATOR

Binaural Beat Music, Spatialized Music, Music Playlist

Other: Personalized Music Listening (PML); Other: Binaural Beat Music (BBM); Other: Spatialized Music (SM)

Interventions

Personalized Music Listening (PML) OTHER

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.

B0S0; B0S1; B1S0; B1S1

Binaural Beat Music (BBM) OTHER

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.

B1S0; B1S1

Spatialized Music (SM) OTHER

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.

B0S1; B1S1

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• CoroHealth LLC: collaborator
• Oxford Health Group LLC: collaborator
• Music in the Space Between LLC: collaborator
• Hollie Kemp Consulting LLC: collaborator
• Maharishi International University: lead

Study Sites (2)

Woodland Estates Senior Living

Denver, Colorado, 80231, United States

RECRUITING

Woodlake Legacy Senior Living

Lakewood, Colorado, 80228, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Paul Oomen, MMus

CONTACT

+36203980356; poomen@nemolabs.info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects enrolled in the study are randomly divided by investigator A into four groups in equal proportions. Each subject will be assigned to a group with a serial number generated randomly by a computer. Investigator B prepares the music interventions for each group. Investigator C implements the interventions on-site and collects data from subjects. Investigator A manages the collected data and performs the statistical analysis. In this study, investigator B and C are blinded to the intervention content for each group, while investigators A and B are blinded to the identities of subjects in each group. Interventions are presented using the same type of headphone and data collected in an identical manner for each intervention. Throughout the trial, participants are required to keep the content they hear through the headphones confidential and not to disclose it to the investigators.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a prospective, randomized, controlled, blinded, and factorial trial. According to a 2×2 factorial design, at each level of the two factors, the participants will be randomly divided into four groups: group B0S0, group B1S0, group B0S1, and group B1S1.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: May 4, 2026
• Primary Completion: June 27, 2026
• Study Completion: June 27, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)