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

NCT05844241 | Completed DMC

• 1 other identifier: LUC101A
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rating of Anxiety in Dementia

  2 weeks

• Cornell Brown Scale for Quality of Life in Dementia

  2 weeks

• Zarit Caregiver Burden Interview

  2 weeks

• Positive and Negative Affect Scale

  30 minutes

• Overt Agitation Severity Scale

  30 minutes

Study Arms (2)

Music and Theta Auditory Beat Stimulation (ABS)

EXPERIMENTAL

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

Other: Music and Theta Auditory Beat Stimulation

Audiobooks

ACTIVE COMPARATOR

Participants listen to a 30-minute audiobook.

Other: Audiobooks

Interventions

Music and Theta Auditory Beat Stimulation OTHER

Listening to music and ABS for 30 minutes.

Music and Theta Auditory Beat Stimulation (ABS)

Audiobooks OTHER

Listening to audiobooks for 30 minutes

Audiobooks

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lucid, Inc.: lead

Study Sites (1)

LUCID Therapeutics

Toronto, Ontario, M5C 1K9, Canada

Location

MeSH Terms

Interventions

Sound Recordings

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Adiel Mallik, PhD

  Lucid, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 6, 2023
• Study Start: May 8, 2023
• Primary Completion: August 2, 2023
• Study Completion: August 3, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-05

Locations

CA (1)