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临床试验/NCT05858541
NCT05858541已完成不适用

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

University of Southern California2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Agitation Trait

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Investigators, and research staff involved in data collection and analysis will be masked to the assignment of participants

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Agitation Trait

时间窗: 8 weeks

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

Agitation State

时间窗: pre and post 20 mins session for a total of 32 sessions

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

次要结局

  • Anxiety(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Assal Habibi

Associate Professor

University of Southern California

研究点 (2)

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