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NCT Number: NCT07775625

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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'

Treatment and study plan

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.

Listening to Storytelling

Other

Participants will listen to calming short stories within 30 minutes.

Primary outcomes

  1. Rating Anxiety in Dementia (RAID)

    Time frame: From enrollment to the end of treatment at 8 weeks.

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

Secondary outcomes

  1. Frequency Following Response (FFR)

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

    FFR is a scalp-recorded neural measure capturing precise subcortical encoding of sound timing, frequency, and speech acoustics.

  2. Heart rate

    Time frame: Measured at baseline up to a week after intervention.

    Heart rate per minute

  3. Blood pressure

    Time frame: Measured at baseline up to a week after intervention.

    Blood pressure measured using a blood pressure machine.

  4. Respiratory Rate

    Time frame: Measured at baseline and up to a week after intervention.

    Number of respirations per minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA

CONTACT

[email protected]

(312) 503-5170

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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