Recruiting

BBM, SM, Combination

Sponsor:

Maharishi International University

Code:

NCT07626944

Conditions

BPSD

Caregiver Distress

Well-being

Mood

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Personalized Music Listening (PML)

Binaural Beat Music (BBM)

Spatialized Music (SM)

Study Details

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

Study ID

NCT07626944

Start date

May 4, 2026

Status verified date

May, 2026

Completion date

Jun 27, 2026

Anticipated

Primary completion date

Jun 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: B0S0

Music playlist (control)

active comparator: B1S0

Binaural Beat Music, Music Playlist

active comparator: B0S1

Spatialized Music, Music Playlist

active comparator: B1S1

Binaural Beat Music, Spatialized Music, Music Playlist

Interventions

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.

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.

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.

Primary outcome measure

  • BPSD Severity - assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Before the start and after completion of a 2 week treatment ]

Central Contacts and Locations

Central contacts

Paul Oomen, MMus

+36203980356poomen@nemolabs.info

Locations

Woodland Estates Senior Living

Recruiting

Denver, Colorado, United States, 80231

Contacts

Anthony Geiser

303-671-2500admin@woodlandsl.com

Principal Investigator:

Hollie Kemp

Woodlake Legacy Senior Living

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

Matthew Wistreich

303-237-5700admin@woodlakesl.com

Principal Investigator:

Hollie Kemp

More Information

Sponsor

Maharishi International University

Last update posted

Jun 4, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maharishi International University on 2026-06-04.