Mild to Moderate DementiaNCT05844241
The Effect of Auditory Interventions on Anxiety and Agitation in People With Dementia
A study testing Music and Theta Auditory Beat Stimulation and Audiobooks in people with Mild to Moderate Dementia, run by Lucid, Inc. at 1 site in Canada.
Trial summary
The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild to Moderate Dementia
- What is being tested?
- Music and Theta Auditory Beat Stimulation and Audiobooks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 8 May 2023to 3 Aug 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 Dementia (mild: Montreal Cognitive Assessment (MOCA) scores (18-25); moderate: MOCA scores (10-17)))
Who cannot join
- Unmanaged hearing loss (defined as average pure-tone average threshold of 35 dB HL or greater without the use of hearing instruments or personal sound amplification product)
- Severe Tinnitus
- Hyperacusis
Trial locations and contacts
1 site in 1 country.
About this study
The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. There is evidence that music interventions reduce agitation and anxiety in those with dementia. LUCID has developed a novel digital music therapeutic product that uses a reinforcement learning AI agent to curate and personalize the musical playlist while incorporating binaural theta auditory beat stimulation (ABS) to reduce anxiety and agitation in those with dementia. This study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being shipped to caregivers/participants' homes. The study will take place over a 2-week period, with participants completing 4 one-hour sessions per week along with an additional 1-hour follow-up interview session. Forty-eight participants with mild to moderate dementia (as defined by the Montreal Cognitive Assessment) will be evenly randomized to one of two conditions. The control condition consists of a selection of 30-minute audiobooks which the participant has the freedom to select from. The experimental condition consists of music and binaural ABS curated by LUCID's AI system. Participants' caregivers will complete baseline questionnaires assessing the participants' anxiety, agitation, and mood. They will also complete these questionnaires before and after each experimental session. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.
Read the detailed description
The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. There is evidence that music interventions reduce agitation and anxiety in those with dementia. LUCID has developed a novel digital music therapeutic product that uses a reinforcement learning AI agent to curate and personalize the musical playlist while incorporating binaural theta auditory beat stimulation (ABS) to reduce anxiety and agitation in those with dementia. This study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being shipped to caregivers/participants' homes. The study will take place over a 2-week period, with participants completing 4 one-hour sessions per week along with an additional 1-hour follow-up interview session. Forty-eight participants with mild to moderate dementia (as defined by the Montreal Cognitive Assessment) will be evenly randomized to one of two conditions. The control condition consists of a selection of 30-minute audiobooks which the participant has the freedom to select from. The experimental condition consists of music and binaural ABS curated by LUCID's AI system. Participants' caregivers will complete baseline questionnaires assessing the participants' anxiety, agitation, and mood. They will also complete these questionnaires before and after each experimental session. Participants and their caregivers will schedule a Zoom call with a Research Assistant (RA) to assist them during their first onboarding session and go over study expectations and participants' rights. Participants/caregivers have access to and the ability to communicate and schedule meetings with RAs at any time should any issues arise over the course of the study. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.
- Conditions
- Mild to Moderate Dementia
- Being tested
- Music and Theta Auditory Beat Stimulation, Audiobooks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and Theta Auditory Beat StimulationOther
Listening to music and ABS for 30 minutes.
AudiobooksOther
Listening to audiobooks for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Music and Theta Auditory Beat Stimulation (ABS) | Experimental | Participants listen to 30 minutes of personalized music with theta auditory beat stimulation (ABS). Receives: Other: Music and Theta Auditory Beat Stimulation |
| Audiobooks | Active comparator | Participants listen to a 30-minute audiobook. Receives: Other: Audiobooks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen Mansfield Agitation Index
The purpose of this scale is to assess the frequency of manifestations of agitated behaviors in elderly persons. Minimum score: 14, Maximum score: 70. Higher score indicates a worse outcome (increased agitation).
Measured: 2 weeks
Secondary outcomes (6)
Rating of Anxiety in Dementia
A rating scale to measure anxiety in those that suffer from dementia. Minimum value: 0, Maximum value: 54. Higher score indicates worse outcome (increased anxiety)
Measured: 2 weeks
Cornell Brown Scale for Quality of Life in Dementia
A scale that measures the quality of life of dementia patients. Minimum score: -38. Maximum score: 38. Higher score indicates better outcome (increased quality of life)
Measured: 2 weeks
Zarit Caregiver Burden Interview
A scale that measures the caregiver burden of those that care for people with dementia and other ailments. Minimum score: 0, Maximum score: 88, Higher score indicates a worse outcome (higher caregiver burden).
Measured: 2 weeks
Positive and Negative Affect Scale
The positive and negative affect scale is a good measure of a person's current mood. This scale generates two scores: 1) Positive affect (a higher score indicates a better outcome), scores range from 10-50. 2) Negative affect (higher score indicates worse outcome), scores range from 10-50.
Measured: 30 minutes
Overt Agitation Severity Scale
A scale that identifies and measures the severity of agitated behavior in those with dementia/Alzheimer's disease. Minimum score: 0, Maximum score: 48. Higher score indicates a worse outcome (higher agitation symptoms).
Measured: 30 minutes
Digit Span Forward
A cognitive measure of working memory.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 May 2023
- Primary completion2 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate DementiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucid, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adiel Mallik, PhD, Principal investigator, Lucid, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844241
- Sponsor's protocol ID
- LUC101A
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auditory Interventions on Anxiety and Agitation in People With Dementia
- ClinicalTrials.gov ID
- NCT05844241
- Acronym / sponsor ID
- LUC101A
- Conditions
- Mild to Moderate Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Lucid, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 6 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.
The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. There is evidence that music interventions reduce agitation and anxiety in those with dementia. LUCID has developed a novel digital music therapeutic product that uses a reinforcement learning AI agent to curate and personalize the musical playlist while incorporating binaural theta auditory beat stimulation (ABS) to reduce anxiety and agitation in those with dementia. This study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being shipped to caregivers/participants' homes. The study will take place over a 2-week period, with participants completing 4 one-hour sessions per week along with an additional 1-hour follow-up interview session. Forty-eight participants with mild to moderate dementia (as defined by the Montreal Cognitive Assessment) will be evenly randomized to one of two conditions. The control condition consists of a selection of 30-minute audiobooks which the participant has the freedom to select from. The experimental condition consists of music and binaural ABS curated by LUCID's AI system. Participants' caregivers will complete baseline questionnaires assessing the participants' anxiety, agitation, and mood. They will also complete these questionnaires before and after each experimental session. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.
Detailed description
The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia. There is an urgent need to develop new, easily scalable modalities of support to reduce agitation and anxiety in those with dementia. There is evidence that music interventions reduce agitation and anxiety in those with dementia. LUCID has developed a novel digital music therapeutic product that uses a reinforcement learning AI agent to curate and personalize the musical playlist while incorporating binaural theta auditory beat stimulation (ABS) to reduce anxiety and agitation in those with dementia. This study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being shipped to caregivers/participants' homes. The study will take place over a 2-week period, with participants completing 4 one-hour sessions per week along with an additional 1-hour follow-up interview session. Forty-eight participants with mild to moderate dementia (as defined by the Montreal Cognitive Assessment) will be evenly randomized to one of two conditions. The control condition consists of a selection of 30-minute audiobooks which the participant has the freedom to select from. The experimental condition consists of music and binaural ABS curated by LUCID's AI system. Participants' caregivers will complete baseline questionnaires assessing the participants' anxiety, agitation, and mood. They will also complete these questionnaires before and after each experimental session. Participants and their caregivers will schedule a Zoom call with a Research Assistant (RA) to assist them during their first onboarding session and go over study expectations and participants' rights. Participants/caregivers have access to and the ability to communicate and schedule meetings with RAs at any time should any issues arise over the course of the study. The investigators hypothesize that the LUCID AI music curation system will have a greater agitation and anxiety reduction compared to the audiobook control condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music and Theta Auditory Beat Stimulation (ABS) | Experimental | Other: Music and Theta Auditory Beat StimulationParticipants listen to 30 minutes of personalized music with theta auditory beat stimulation (ABS). |
| Audiobooks | Active comparator | Other: AudiobooksParticipants listen to a 30-minute audiobook. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Mild to Moderate Dementia (mild: Montreal Cognitive Assessment (MOCA) scores (18-25); moderate: MOCA scores (10-17)))
Key exclusion criteria (3 listed)
- Unmanaged hearing loss (defined as average pure-tone average threshold of 35 dB HL or greater without the use of hearing instruments or personal sound amplification product)
- Severe Tinnitus
- Hyperacusis
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 and Theta Auditory Beat StimulationListening to music and ABS for 30 minutes. | Other | Music and Theta Auditory Beat Stimulation (ABS) |
| AudiobooksListening to audiobooks for 30 minutes | Other | Audiobooks |
Primary outcome
Cohen Mansfield Agitation Index
Time frame: 2 weeks
The purpose of this scale is to assess the frequency of manifestations of agitated behaviors in elderly persons. Minimum score: 14, Maximum score: 70. Higher score indicates a worse outcome (increased agitation).
6 secondary outcomes
Rating of Anxiety in Dementia
Time frame: 2 weeks
Cornell Brown Scale for Quality of Life in Dementia
Time frame: 2 weeks
Zarit Caregiver Burden Interview
Time frame: 2 weeks
Positive and Negative Affect Scale
Time frame: 30 minutes
Overt Agitation Severity Scale
Time frame: 30 minutes
Digit Span Forward
Time frame: 30 minutes
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 22 Nov 2023.
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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.
Adiel Mallik, PhD principal investigator
Lucid, Inc.
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 and Theta Auditory Beat Stimulation and Audiobooks in people with Mild to Moderate Dementia, run by Lucid, Inc. at 1 site in Canada.
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 1 inclusion and 3 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 22 Nov 2023. 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 Canada. 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?
Cohen Mansfield Agitation Index (time frame: 2 weeks). 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 22 Nov 2023.