The Effect of Auditory Interventions on Anxiety and Agitation in People With Dementia

The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. There is evidence that music interventions reduce agitation and anxiety in those with dementia. LUCID has developed a novel digital music therapeutic product that uses a reinforcement learning AI agent to curate and personalize the musical playlist while incorporating binaural theta auditory beat stimulation (ABS) to reduce anxiety and agitation in those with dementia. This study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being shipped to caregivers/participants' homes. The study will take place over a 2-week period, with participants completing 4 one-hour sessions per week along with an additional 1-hour follow-up interview session. Forty-eight participants with mild to moderate dementia (as defined by the Montreal Cognitive Assessment) will be evenly randomized to one of two conditions. The control condition consists of a selection of 30-minute audiobooks which the participant has the freedom to select from. The experimental condition consists of music and binaural ABS curated by LUCID's AI system. Participants' caregivers will complete baseline questionnaires assessing the participants' anxiety, agitation, and mood. They will also complete these questionnaires before and after each experimental session. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Dementia
• Intervention / Treatment: Other: Music and Theta Auditory Beat Stimulation; Other: Audiobooks

Detailed Description

The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. There is evidence that music interventions reduce agitation and anxiety in those with dementia. LUCID has developed a novel digital music therapeutic product that uses a reinforcement learning AI agent to curate and personalize the musical playlist while incorporating binaural theta auditory beat stimulation (ABS) to reduce anxiety and agitation in those with dementia. This study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being shipped to caregivers/participants' homes. The study will take place over a 2-week period, with participants completing 4 one-hour sessions per week along with an additional 1-hour follow-up interview session. Forty-eight participants with mild to moderate dementia (as defined by the Montreal Cognitive Assessment) will be evenly randomized to one of two conditions. The control condition consists of a selection of 30-minute audiobooks which the participant has the freedom to select from. The experimental condition consists of music and binaural ABS curated by LUCID's AI system. Participants' caregivers will complete baseline questionnaires assessing the participants' anxiety, agitation, and mood. They will also complete these questionnaires before and after each experimental session. Participants and their caregivers will schedule a Zoom call with a Research Assistant (RA) to assist them during their first onboarding session and go over study expectations and participants' rights. Participants/caregivers have access to and the ability to communicate and schedule meetings with RAs at any time should any issues arise over the course of the study. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adiel Mallik, PhD; Phone Number: 514-835-8514; Email: adiel@thelucidproject.ca
• Study Contact Backup: Name: Rhiannon Ueberholz, BSc; Phone Number: 416-357-5321; Email: rhiannon@thelucidproject.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 1K9
      • LUCID Therapeutics

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Mild to Moderate Dementia (mild: Montreal Cognitive Assessment (MOCA) scores (18-25); moderate: MOCA scores (10-17)))

Exclusion Criteria:

• Unmanaged hearing loss (defined as average pure-tone average threshold of 35 dB HL or greater without the use of hearing instruments or personal sound amplification product)
• Severe Tinnitus
• Hyperacusis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music and Theta Auditory Beat Stimulation (ABS); Participants listen to 30 minutes of personalized music with theta auditory beat stimulation (ABS).	Other: Music and Theta Auditory Beat Stimulation; Listening to music and ABS for 30 minutes.
Active Comparator: Audiobooks; Participants listen to a 30-minute audiobook.	Other: Audiobooks; Listening to audiobooks for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohen Mansfield Agitation Index	The purpose of this scale is to assess the frequency of manifestations of agitated behaviors in elderly persons. Minimum score: 14, Maximum score: 70. Higher score indicates a worse outcome (increased agitation).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating of Anxiety in Dementia	A rating scale to measure anxiety in those that suffer from dementia. Minimum value: 0, Maximum value: 54. Higher score indicates worse outcome (increased anxiety)	2 weeks
Cornell Brown Scale for Quality of Life in Dementia	A scale that measures the quality of life of dementia patients. Minimum score: -38. Maximum score: 38. Higher score indicates better outcome (increased quality of life)	2 weeks
Zarit Caregiver Burden Interview	A scale that measures the caregiver burden of those that care for people with dementia and other ailments. Minimum score: 0, Maximum score: 88, Higher score indicates a worse outcome (higher caregiver burden).	2 weeks
Positive and Negative Affect Scale	The positive and negative affect scale is a good measure of a person's current mood. This scale generates two scores: 1) Positive affect (a higher score indicates a better outcome), scores range from 10-50. 2) Negative affect (higher score indicates worse outcome), scores range from 10-50.	30 minutes
Overt Agitation Severity Scale	A scale that identifies and measures the severity of agitated behavior in those with dementia/Alzheimer's disease. Minimum score: 0, Maximum score: 48. Higher score indicates a worse outcome (higher agitation symptoms).	30 minutes
Digit Span Forward	A cognitive measure of working memory.	30 minutes

Collaborators and Investigators

• Sponsor: Lucid, Inc.
• Investigators: Principal Investigator: Adiel Mallik, PhD, Lucid, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: LUC101A

Drug and device information, study documents

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