The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment

Advancing age is associated with an increased risk of developing dementia which can lead to a rapid acceleration in both the healthcare costs and caregiver burden. There is a need to develop non-pharmacological and easily accessible modalities of support for the well-being and enhancing quality of life for individuals with dementia. There is evidence that music listening is associated with stress and anxiety reduction in older adults. Here, the investigators aim to assess the effects of music listening as provided by a novel digital music-based intervention (developed by LUCID) on mood, anxiety, and quality of life in individuals at the early stages of dementia. LUCID uses reinforcement learning machine learning to curate and personalize the musical playlist while incorporating monoaural theta auditory beat stimulation (ABS) into the music. The study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being delivered to caregivers/participants. The study will take place over an 8- week period, with participants completing four 30 mins music or audiobook listening sessions per week. Pre and post-intervention assessments will be done via Zoom with the presence of a research staff member. The control condition consists of a randomized list of short audiobooks. The experimental condition consists of music and monoaural ABS curated by LUCID's AI system. The investigators hypothesize that the LUCID AI music curation system, compared to audiobooks, will be correlated with a greater reduction in measures of anxiety and agitation and an enhancement of mood and quality of life.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Agitated Depression
• Intervention / Treatment: Behavioral: Music Listening; Behavioral: Listening to Audiobooks

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Assal Habibi; Phone Number: 2137403588; Email: ahabibi@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • Recruiting
      • University of Southern California
      • Contact: Assal Habibi; Phone Number: 213-740-3588; Email: ahabibi@usc.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Mild to Moderate Cognitive Impairment (mild: MOCA scores (18-25); moderate: MOCA scores (10-17))
• Aged 65-85.

Exclusion Criteria:

• Unmanaged hearing loss (defined as the average pure-tone average threshold of 35 dB HL or greater without the use of hearing instruments or personal sound amplification product) - self-report
• Severe Tinnitus
• Hyperacusis
• Current (but not prior) severe psychiatric disorder, an unstable or serious medical condition that may limit participation in the assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Listening; Music Intervention - Music selection by LUCID The AI-based system for song selection responds to the collected measurement data (video and HRV) and music preference information (like/dislike button, music taste profile) to recommend the playlist for the listener. The songs are selected using 76 different musical features and raw audio information. The system uses these features to recommend and optimize recommendations for the listener. The video is only temporarily streamed from the device to extract a series of facial features to assist in music selection. This data stream is sent to the LUCID cloud platform via encrypted data in transit protocol; the facial features are extracted, and the video is deleted. The facial feature data, even when reconstructed, is not identifiable. No personally identifiable biometric measures are stored in LUCID servers at any time	Behavioral: Music Listening; The LUCID AI-based system for song selection responds to the collected measurement data (video and HRV) and music preference information (like/dislike button, music taste profile) to recommend the playlist for the listener. The songs are selected using 76 different musical features and raw audio information. The system uses these features to recommend and optimize recommendations for the listener
Active Comparator: Audiobooks; Audiobook selection A selection of 40 audiobooks spanning 4 genres (10 each from Literary Classics, Fantasy, Mystery, Non-fiction) will be available. For each session, the participant and their caregiver will be given a prompt to make a genre selection. After making the genre selection, one of the ten stories associated with that genre will be selected at random. All stories were sampled from the Audible audiobook database. Stories had to be 30 minutes in length to align with the length of the music interventions and the selected stories had to have had a 4- or 5-star rating to ensure quality.	Behavioral: Listening to Audiobooks; A selection of 40 audiobooks spanning 4 genres (10 each from Literary Classics, Fantasy, Mystery, Non-fiction) will be available. For each session, the participant and their caregiver will be given a prompt to make a genre selection. After making the genre selection, one of the ten stories associated with that genre will be selected at random. All stories were sampled from the Audible audiobook database. Stories had to be 30 minutes in length to align with the length of the music interventions and the selected stories had to have had a 4- or 5-star rating to ensure quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agitation Trait	Change in agitation as measured by the Cohen-Mansfield Agitation Index	8 weeks
Agitation State	Change in agitation as measured by Overt Agitation Scale (OAS)	pre and post 20 mins session for a total of 32 sessions
Agitation State	Change in agitation as measured by Positive and Negative Syndrome Scale, Excited Component (PANSS-EC)	pre and post 20 mins session for a total of 32 sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Change in Anxiety in Dementia Scale (RAID)-Minimum value: 0, Maximum value: 54. Higher score	8 weeks
Anxiety	Change in State-trait cognitive and somatic anxiety (STICSA)	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Change in depression as measured by Geriatric Depression Scale 0 is minimum and 15 is maximum with 15 being highest rate of depression	8 weeks
Well-being	Change in quality of life as measured by Cornell Brown Scale for Quality of Life in Dementia - Minimum score: -38. Maximum score: 38. Higher score indicates better outcome (increased quality of life)	8 weeks
Caregiver Burden	Change in caregiver burden measured by Zarit caregiver burden	8 weeks
Anxiety and Mood	Change in Mood and Anxiety as measured by PANAS Positive and Negative Affect Schedule	pre and post 20 mins session for a total of 32 sessions
Arousal	Change in affect as measured by high low arousal	pre and post 20 mins session for a total of 32 sessions
Valence	Change in affect as measured by positive negative valence	pre and post 20 mins session for a total of 32 sessions
Memory	Changes in memory recall measured by vividness and specificity of recalled memories	8 weeks

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Anxiety Disorders; Cognitive Dysfunction
• Other Study ID Numbers: APP-23-02029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data and protocol will be available upon completion of the data and analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

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