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

Primary Purpose

Anxiety, Agitated Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Listening
Listening to Audiobooks
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Listening

Audiobooks

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Anxiety
Change in anxiety from pre to post intervention as measured by Rate of Anxiety in Dementia Scale (RAID)-Minimum value: 0, Maximum value: 54. Higher score indicates worse outcome (increased anxiety)

Secondary Outcome Measures

Agitation
Change in agitation from pre to post intervention as measured by Neuropsychiatric -Inventory Caregiver Distress Scale.0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=very severe distress). Score range 0-5

Full Information

First Posted
April 28, 2023
Last Updated
June 5, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05858541
Brief Title
The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment
Official Title
The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Agitated Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators, and research staff involved in data collection and analysis will be masked to the assignment of participants
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Listening
Arm Type
Experimental
Arm Description
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
Arm Title
Audiobooks
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music Listening
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Listening to Audiobooks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
Change in anxiety from pre to post intervention as measured by Rate of Anxiety in Dementia Scale (RAID)-Minimum value: 0, Maximum value: 54. Higher score indicates worse outcome (increased anxiety)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Agitation
Description
Change in agitation from pre to post intervention as measured by Neuropsychiatric -Inventory Caregiver Distress Scale.0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=very severe distress). Score range 0-5
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Depression
Description
Change in depression as measured by Geriatric Depression Scale 0 is minimum and 15 is maximum with 15 being highest rate of depression
Time Frame
8 weeks
Title
Well-being
Description
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)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Assal Habibi
Phone
2137403588
Email
ahabibi@usc.edu
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assal Habibi
Phone
213-740-3588
Email
ahabibi@usc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
The data and protocol will be available upon completion of the data and analysis

Learn more about this trial

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

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