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Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Both interventions include eight 30-minute sessions over four weeks, delivered in alternating in-person and virtual formats."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether listening to live, calming music can reduce anxiety in people with Alzheimer's disease and ease the strain on their caregivers. It compares music with calming stories read aloud during eight 30-minute sessions over four weeks. It also looks at how the brain handles sound.

This study examines whether Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in people living with Alzheimer's disease and anxiety (AD-A), and whether it can also lessen caregiver burden. CDIM is a live, receptive music-based intervention that uses slow tempi, simple diatonic melodic lines, soft dynamics, and periodic pauses to promote relaxation. As described in the proposal, CDIM has previously been shown to reduce stress and improve physiological markers such as heart rate, blood pressure, and EEG alpha/beta ratios (CDIM significantly decreased physical stress symptoms and patients also reported positive emotional outcomes and EEG readings showed increased alpha/beta brainwave ratios ). The study will enroll 30 dyads (individuals with AD-A and their caregivers). Dyads will be randomly assigned to either CDIM or a control intervention (CI) consisting of calming short stories read aloud. Both interventions include eight 30-minute sessions over four weeks, delivered in alternating in-person and virtual formats. The primary goal is to determine whether CDIM is feasible and effective in reducing anxiety in individuals with AD-A, measured by the Rating Anxiety in Dementia (RAID) scale, and in reducing caregiver burden, measured by the Zarit Burden Interview (ZBI). The study also evaluates changes in heart rate and blood pressure as indicators of autonomic regulation. A second goal is to explore whether CDIM improves central auditory processing, assessed using the frequency-following response (FFR). The proposal notes that central auditory processing declines with age and dementia and may contribute to anxiety. FFR will be measured before and after the intervention to determine whether CDIM enhances neural timing and response magnitude. Overall, this pilot study aims to determine whether CDIM is a feasible, safe, and potentially effective non-pharmacological intervention for reducing anxiety in individuals with AD-A and decreasing caregiver burden, while also investigating its underlying neurophysiological mechanisms.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have an Alzheimer's disease diagnosis from a health care provider.
  • Have test results showing signs of Alzheimer's disease in blood, a brain scan called an amyloid PET scan, or fluid around the brain and spinal cord.
  • Score 15 or higher on the Mini-Mental State Exam, a test of memory and thinking.
  • Score above 8 on the Rating Anxiety in Dementia scale, which measures anxiety.

Who can't join

  • Have major hearing problems.
  • Have other major health conditions.
  • Score above 10 on the Beck Depression Inventory, a questionnaire about depression symptoms.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * Clinical diagnosis of Alzheimer's Disease * Positive Alzheimer's disease biomarkers (blood test, amyloid PET scan or CSF) * Mini-mental State Exam (MMSE) \>=15 * Rating for Anxiety in Dementia (RAID) score \> 8 Exclusion Criteria * Significant hearing impairments * Major comorbidities Beck Depression Inventory (BDI) scores above \> 10'

Study sites (1)

IL