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Completed

NCT Number: NCT05858541

The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music listening

Behavioral

The LUCID AI-based system for song selection responds to the collected measurement data (video and HRV) and music preference information (like/dislike button, music taste profile) to recommend the playlist for the listener. The songs are selected using 76 different musical features and raw audio information. The system uses these features to recommend and optimize recommendations for the listener

Listening to Audiobooks

Behavioral

A selection of 40 audiobooks spanning 4 genres (10 each from Literary Classics, Fantasy, Mystery, Non-fiction) will be available. For each session, the participant and their caregiver will be given a prompt to make a genre selection. After making the genre selection, one of the ten stories associated with that genre will be selected at random. All stories were sampled from the Audible audiobook database. Stories had to be 30 minutes in length to align with the length of the music interventions and the selected stories had to have had a 4- or 5-star rating to ensure quality.

Primary outcomes

  1. Agitation Trait

    Time frame: 8 weeks

    Change in agitation as measured by the Cohen-Mansfield Agitation Index

  2. Agitation State

    Time frame: pre and post 20 mins session for a total of 32 sessions

    Change in agitation as measured by Overt Agitation Scale (OAS)

  3. Agitation State

    Time frame: pre and post 20 mins session for a total of 32 sessions

    Change in agitation as measured by Positive and Negative Syndrome Scale, Excited Component (PANSS-EC)

Secondary outcomes

  1. Anxiety

    Time frame: 8 weeks

    Change in Anxiety in Dementia Scale (RAID)-Minimum value: 0, Maximum value: 54. Higher score

  2. Anxiety

    Time frame: 8 weeks

    Change in State-trait cognitive and somatic anxiety (STICSA)

Other outcomes

  1. Depression

    Time frame: 8 weeks

    Change in depression as measured by Geriatric Depression Scale 0 is minimum and 15 is maximum with 15 being highest rate of depression

  2. Well-being

    Time frame: 8 weeks

    Change in quality of life as measured by Cornell Brown Scale for Quality of Life in Dementia - Minimum score: -38. Maximum score: 38. Higher score indicates better outcome (increased quality of life)

  3. Caregiver Burden

    Time frame: 8 weeks

    Change in caregiver burden measured by Zarit caregiver burden

  4. Anxiety and Mood

    Time frame: pre and post 20 mins session for a total of 32 sessions

    Change in Mood and Anxiety as measured by PANAS Positive and Negative Affect Schedule

  5. Arousal

    Time frame: pre and post 20 mins session for a total of 32 sessions

    Change in affect as measured by high low arousal

  6. Valence

    Time frame: pre and post 20 mins session for a total of 32 sessions

    Change in affect as measured by positive negative valence

  7. Memory

    Time frame: 8 weeks

    Changes in memory recall measured by vividness and specificity of recalled memories

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 15, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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