The Effect of Auditory Interventions on Anxiety and Agitation in People With Dementia

November 21, 2023 updated by: Lucid, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 1K9
        • LUCID Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mild to Moderate Dementia (mild: Montreal Cognitive Assessment (MOCA) scores (18-25); moderate: MOCA scores (10-17)))

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music and Theta Auditory Beat Stimulation (ABS)
Participants listen to 30 minutes of personalized music with theta auditory beat stimulation (ABS).
Other: Music and Theta Auditory Beat Stimulation
Listening to music and ABS for 30 minutes.
Active Comparator: Audiobooks
Participants listen to a 30-minute audiobook.
Other: Audiobooks
Listening to audiobooks for 30 minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rating of Anxiety in Dementia
Time Frame: 2 weeks
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)
2 weeks
Cornell Brown Scale for Quality of Life in Dementia
Time Frame: 2 weeks
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)
2 weeks
Zarit Caregiver Burden Interview
Time Frame: 2 weeks
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).
2 weeks
Positive and Negative Affect Scale
Time Frame: 30 minutes
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.
30 minutes
Overt Agitation Severity Scale
Time Frame: 30 minutes
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).
30 minutes
Digit Span Forward
Time Frame: 30 minutes
A cognitive measure of working memory.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lucid, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adiel Mallik, PhD, Lucid, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUC101A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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