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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA
- Telefonnummer: (312) 503-5170
- E-post: bbk@northwestern.edu
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Rekruttering
- Northwestern University Feinberg School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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'
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Clinically Designed Improvisatory Music
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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.
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Aktiv komparator: Listening to storytelling
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Participants will listen to calming short stories within 30 minutes.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Rating Anxiety in Dementia (RAID)
Tidsramme: From enrollment to the end of treatment at 8 weeks.
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RAID is a structured clinical scale measuring anxiety in dementia.
It will be evaluated 3 times, 4 weeks apart.
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From enrollment to the end of treatment at 8 weeks.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Frequency Following Response (FFR)
Tidsramme: It will be evaluated at baseline and up to a week after intervention.
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FFR is a scalp-recorded neural measure capturing precise subcortical encoding of sound timing, frequency, and speech acoustics.
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It will be evaluated at baseline and up to a week after intervention.
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Heart rate
Tidsramme: Measured at baseline up to a week after intervention.
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Heart rate per minute
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Measured at baseline up to a week after intervention.
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Blood pressure
Tidsramme: Measured at baseline up to a week after intervention.
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Blood pressure measured using a blood pressure machine.
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Measured at baseline up to a week after intervention.
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Respiratory Rate
Tidsramme: Measured at baseline and up to a week after intervention.
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Number of respirations per minutes.
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Measured at baseline and up to a week after intervention.
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU00215983-MOD0004
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