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

NCT ID: NCT05844241

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2023-08-03

Brief Summary

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.

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.

Conditions

Mild to Moderate Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Music and Theta Auditory Beat Stimulation (ABS)

Participants listen to 30 minutes of personalized music with theta auditory beat stimulation (ABS).

Group Type: EXPERIMENTAL

Music and Theta Auditory Beat Stimulation

Intervention Type: OTHER

Listening to music and ABS for 30 minutes.

Audiobooks

Participants listen to a 30-minute audiobook.

Group Type: ACTIVE_COMPARATOR

Audiobooks

Intervention Type: OTHER

Listening to audiobooks for 30 minutes

Interventions

Music and Theta Auditory Beat Stimulation

Listening to music and ABS for 30 minutes.

Intervention Type: OTHER

Audiobooks

Listening to audiobooks for 30 minutes

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lucid, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adiel Mallik, PhD

Role: PRINCIPAL_INVESTIGATOR

Lucid, Inc.

Locations

LUCID Therapeutics

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

LUC101A

Identifier Type: -

Identifier Source: org_study_id