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NCT05858541 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Southern California.

Completed
Registry status
NA
Development phase
64
Enrollment target

NCT05858541: Completed NA study, sponsored by University of Southern California.

NCT05858541 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05858541, a NA study, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
NA
Development phase
64 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • BEHAVIORAL Music Listening
  • BEHAVIORAL Listening to Audiobooks

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2023-06-01
Est. Completion 2023-12-30
Phase NA
University of Southern California

617 total trials

What the finished NCT05858541 record still lists

NCT05858541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Music Listening is the first listed.

NCT05858541 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05858541 about?

NCT05858541 is a clinical study titled "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 l...

What is the current status of trial NCT05858541?

This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2023-06-01. Estimated completion is 2023-12-30.

What interventions are being tested in trial NCT05858541?

The interventions under investigation include: Music Listening (BEHAVIORAL), Listening to Audiobooks (BEHAVIORAL).

Who is sponsoring clinical trial NCT05858541?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05858541's enrollment target sits among peer trials

64 1147th of 2000 higher than 844 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05858541, the US trial registry maintained by the National Library of Medicine. NCT05858541 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.