AnxietyNCT05858541
The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment
A study testing Music Listening and Listening to Audiobooks in people with Anxiety and Agitated Depression, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Anxiety, Agitated Depression
- What is being tested?
- Music Listening and Listening to Audiobooks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mild to Moderate Cognitive Impairment (mild: MOCA scores (18-25); moderate: MOCA scores (10-17))
- Aged 65-85.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
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.
- Conditions
- Anxiety, Agitated Depression
- Being tested
- Music Listening, Listening to Audiobooks
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningBehavioural
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 AudiobooksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Listening | Experimental | Music Intervention - Music selection by LUCID The 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. The video is only temporarily streamed from the device to extract a series of facial features to assist in music selection. This data stream is sent to the LUCID cloud platform via encrypted data in transit protocol; the facial features are extracted, and the video is deleted. The facial feature data, even when reconstructed, is not identifiable. No personally identifiable biometric measures are stored in LUCID servers at any time Receives: Behavioral: Music Listening |
| Audiobooks | Active comparator | Audiobook selection 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. Receives: Behavioral: Listening to Audiobooks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation Trait
Change in agitation as measured by the Cohen-Mansfield Agitation Index
Measured: 8 weeks
Agitation State
Change in agitation as measured by Overt Agitation Scale (OAS)
Measured: pre and post 20 mins session for a total of 32 sessions
Agitation State
Change in agitation as measured by Positive and Negative Syndrome Scale, Excited Component (PANSS-EC)
Measured: pre and post 20 mins session for a total of 32 sessions
Secondary outcomes (2)
Anxiety
Change in Anxiety in Dementia Scale (RAID)-Minimum value: 0, Maximum value: 54. Higher score
Measured: 8 weeks
Anxiety
Change in State-trait cognitive and somatic anxiety (STICSA)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assal Habibi, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858541
- Sponsor's protocol ID
- APP-23-02029
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05858541
- Acronym / sponsor ID
- APP-23-02029
- Conditions
- Anxiety, Agitated Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Listening | Experimental | Behavioral: Music ListeningMusic Intervention - Music selection by LUCID The 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. The video is only temporarily streamed from the device to extract a series of facial features to assist in music selection. This data stream is sent to the LUCID cloud platform via encrypted data in transit protocol; the facial features are extracted, and the video is deleted. The facial feature data, even when reconstructed, is not identifiable. No personally identifiable biometric measures are stored in LUCID servers at any time |
| Audiobooks | Active comparator | Behavioral: Listening to AudiobooksAudiobook selection 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Mild to Moderate Cognitive Impairment (mild: MOCA scores (18-25); moderate: MOCA scores (10-17))
- Aged 65-85.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ListeningThe 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 | Behavioural | Music Listening |
| Listening to AudiobooksA 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. | Behavioural | Audiobooks |
Primary outcome
Agitation Trait
Time frame: 8 weeks
Change in agitation as measured by the Cohen-Mansfield Agitation Index
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)
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)
2 secondary outcomes
Anxiety
Time frame: 8 weeks
Anxiety
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening and Listening to Audiobooks in people with Anxiety and Agitated Depression, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation Trait (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.