NCT05844241

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

Completed NA Last updated 22 November 2023

What this trial tests

NA trial testing Music and Theta Auditory Beat Stimulation in Mild to Moderate Dementia in 48 participants. Completed in 3 August 2023.

Timeline

8 May 2023

Primary endpoint
2 August 2023

3 August 2023

Quick facts

Lead sponsor	Lucid, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	48
Start date	8 May 2023
Primary completion	2 August 2023
Estimated completion	3 August 2023
Sites	1 location across Canada

Drugs / interventions tested

• Music and Theta Auditory Beat Stimulation
• Audiobooks

Conditions studied

• Mild to Moderate Dementia — all drugs for Mild to Moderate Dementia →

Sponsor

Lucid, Inc.

Who can join

Adults 65 to 85, any sex, with Mild to Moderate Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.