Clinical trial NCT05858541: The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment
Official title: The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Agitated Depression
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Advancing age is associated with an increased risk of developing dementia which can lead to a rapid acceleration in both the healthcare costs and caregiver burden. There is a need to develop non-pharmacological and easily accessible modalities of support for the well-being and enhancing quality of life for individuals with dementia. There is evidence that music listening is associated with stress and anxiety reduction in older adults. Here, the investigators aim to assess the effects of music listening as provided by a novel digital music-based intervention (developed by LUCID) on mood, anxiety, and quality of life in individuals at the early stages of dementia. LUCID uses reinforcement learning machine learning to curate and personalize the musical playlist while incorporating monoaural theta auditory beat stimulation (ABS) into the music. The study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being delivered to caregivers/participants. The study will take place over an 8- week period, with participants completing four 30 mins music or audiobook listening sessions per week. Pre and post-intervention assessments will be done via Zoom with the presence of a research staff member. The control condition consists of a randomized list of short audiobooks. The experimental condition consists of music and monoaural ABS curated by LUCID's AI system. The investigators hypothesize that the LUCID AI music curation system, compared to audiobooks, will be correlated with a greater reduction in measures of anxiety and agitation and an enhancement of mood and quality of life.


Eligibility criteria: Inclusion Criteria:

* Mild to Moderate Cognitive Impairment (mild: MOCA scores (18-25); moderate: MOCA scores (10-17))
* Aged 65-85.

Exclusion Criteria:

* Unmanaged hearing loss (defined as the average pure-tone average threshold of 35 dB HL or greater without the use of hearing instruments or personal sound amplification product) - self-report
* Severe Tinnitus
* Hyperacusis
* Current (but not prior) severe psychiatric disorder, an unstable or serious medical condition that may limit participation in the assessments.

Primary outcomes:
measure: Agitation Trait
timeFrame: 8 weeks
measure: Agitation State
timeFrame: pre and post 20 mins session for a total of 32 sessions
measure: Agitation State
timeFrame: pre and post 20 mins session for a total of 32 sessions
Secondary outcomes:
measure: Anxiety
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
Other outcomes:
measure: Depression
timeFrame: 8 weeks
measure: Well-being
timeFrame: 8 weeks
measure: Caregiver Burden
timeFrame: 8 weeks
measure: Anxiety and Mood
timeFrame: pre and post 20 mins session for a total of 32 sessions
measure: Arousal
timeFrame: pre and post 20 mins session for a total of 32 sessions
measure: Valence
timeFrame: pre and post 20 mins session for a total of 32 sessions
measure: Memory
timeFrame: 8 weeks
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: