Efficacy of Gamma Auditory Stimulation for Cognitive Decline in Older Adults (Study 1)

NCT07087951 | Not Yet Recruiting

• 1 other identifier: 202402079B0A3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Therefore, this study will use a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.

Conditions

EEG Brain Oscillations; Alzheimer's Disease (AD) and Related Disorders; Cognitive Dysfunction

Keywords

endogenous gamma; EEG rhythms; resting-state EEG (rs-EEG); Alzheimer's disease (AD); Cognitive function; auditory stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in neurophysiological function.

  The changes of power spectral density (PSD) and functional connectivity (FC) at each frequency band will be analyzed by EEG data from each subject.

  baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)

Secondary Outcomes (14)

• Change score of the Chinese version Verbal Learning Test (CVVLT).

  baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)

• Change score of the WMS-III logical memory test

  baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)

• Change score of the Taylor Complex Figure Test (TCFT).

  baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)

• Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

  baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)

• Change score of the Cognitive Abilities Screening Instrument (CASI).

  baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)

Study Arms (2)

40Hz music group

EXPERIMENTAL

The 40Hz music is combined with 40Hz sound and music.

Device: Gamma auditory stimulation device (active setting)

Non-40Hz music group

SHAM COMPARATOR

The non-40Hz music is combined with non-40Hz sound and music.

Device: Gamma auditory stimulation device (sham setting)

Interventions

Gamma auditory stimulation device (active setting) DEVICE

Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours.

40Hz music group

Gamma auditory stimulation device (sham setting) DEVICE

Participants will receive auditory stimulation using the gamma auditory stimulation device (sham setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours.

Non-40Hz music group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 60 years old.
• MMSE≤ 24
• CDR scores of 0.5 and 1
• Voluntary to sign the Informed Consent Form.

You may not qualify if:

• Diagnosis of other psychiatric or neurological disorders
• Drug or alcohol addictions.
• Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.
• History of clinical stroke, major depressive disorder or dysthymic disorder according to the DSM-5.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, Guishan, 33302, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chia-Hsiung Cheng, Ph.D.

CONTACT

+886-3-211800; ch.cheng@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)