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

NCT ID: NCT07087951

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-01

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.

Detailed Description

Amyloid-beta (Aβ) aggregation and hyperphosphorylated tau protein tangles are widely recognized as the main pathological features of Alzheimer's disease (AD). Numerous domestic and international studies have demonstrated that 40 Hz gamma visual stimulation can effectively enhance 40 Hz gamma neural oscillations in healthy adults and older adults, improve cognitive performance and memory function in older adults and individuals with AD, and has shown good safety with no severe adverse effects.

Nevertheless, there are still several limitations to using 40 Hz visual stimulation as an intervention. Extended exposure to light sources may cause discomfort, affecting participants' willingness to continue. Prolonged light exposure may also increase the risk of seizures in photosensitive individuals. In addition, participants are required to actively fixate on the light source, which may reduce intervention adherence. Most importantly, the ecological validity of light-based stimulation remains low. Many studies require participants to gaze at light for at least five minutes or more, and daily sessions of up to an hour over several months are challenging to implement in daily life. To address these limitations, this project proposes using 40 Hz auditory stimulation as a more practical and sustainable intervention.

Moreover, animal studies have confirmed that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, evidence on the independent application of 40 Hz auditory stimulation in humans remains limited. Therefore, this project will adopt 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

40Hz music group

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

Group Type: EXPERIMENTAL

Gamma auditory stimulation device (active setting)

Intervention Type: 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.

Non-40Hz music group

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

Group Type: SHAM_COMPARATOR

Gamma auditory stimulation device (sham setting)

Intervention Type: 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.

Interventions

Gamma auditory stimulation device (active setting)

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.

Intervention Type: DEVICE

Gamma auditory stimulation device (sham setting)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age over 60 years old.

2. MMSE≤ 24

3. CDR scores of 0.5 and 1

4. Voluntary to sign the Informed Consent Form.

Exclusion Criteria

1. Diagnosis of other psychiatric or neurological disorders

2. Drug or alcohol addictions.

3. Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.

4. History of clinical stroke, major depressive disorder or dysthymic disorder according to the DSM-5.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung University

Taoyuan District, Guishan, Taiwan

Countries

Taiwan

Central Contacts

Chia-Hsiung Cheng, Ph.D.

Role: CONTACT

ch.cheng@mail.cgu.edu.tw

+886-3-211800 ext. 3854

Facility Contacts

Chia-Hsiung Cheng, Ph.D.

Role: primary

ch.cheng@mail.cgu.edu.tw

+886-3-211800 ext. 3854

Other Identifiers

202402079B0A3

Identifier Type: -

Identifier Source: org_study_id