The Effect of Auditory Interventions on Anxiety and Agitation in People With Dementia
Condition: Mild to Moderate Dementia
MeSH terms: Dementia
Study type: Interventional

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.
    

Intervention name(s): Music and Theta Auditory Beat Stimulation; Audiobooks
Intervention type(s): Other; Other
Intervention description(s): Listening to music and ABS for 30 minutes.; Listening to audiobooks for 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care