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

NCT07775625 | Recruiting

• 1 other identifier: STU00215983-MOD0004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Music-based intervention; Anxiety; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Rating Anxiety in Dementia (RAID)

  RAID is a structured clinical scale measuring anxiety in dementia. It will be evaluated 3 times, 4 weeks apart.

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (4)

• Frequency Following Response (FFR)

  It will be evaluated at baseline and up to a week after intervention.

• Heart rate

  Measured at baseline up to a week after intervention.

• Blood pressure

  Measured at baseline up to a week after intervention.

• Respiratory Rate

  Measured at baseline and up to a week after intervention.

Study Arms (2)

Clinically Designed Improvisatory Music

EXPERIMENTAL

Other: Clinically Designed Improvisatory Music

Listening to storytelling

ACTIVE COMPARATOR

Other: Listening to Storytelling

Interventions

Clinically Designed Improvisatory Music OTHER

Clinically Designed Improvisatory Music (CDIM) is live, slow-tempo, diatonic improvisation played with soft dynamics and periodic pauses. It uses meterless melodic lines, vocal-range pitches, and gentle harmonic intervals to promote neural entrainment, parasympathetic activation, and anxiety reduction in listeners.

Clinically Designed Improvisatory Music

Listening to Storytelling OTHER

Participants will listen to calming short stories within 30 minutes.

Listening to storytelling

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant hearing impairments
• Major comorbidities Beck Depression Inventory (BDI) scores above \> 10'

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Related Links

• NU MDRN CITATIONS PDF FILE

MeSH Terms

Conditions

Alzheimer Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA

CONTACT

(312) 503-5170; bbk@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 20, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)