Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults
NCT ID: NCT06715995
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2024-12-09
2025-09-30
Brief Summary
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Detailed Description
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This study will recruit 52 cognitively healthy older adults aged 55 and above (N= 52). Participants will be randomly assigned to either the experimental group (N=26), receiving endogenous gamma non-flickering light stimulation, or the control sham group (N=26), receiving 70 Hz non-flickering light stimulation. The intervention will consist of 1 hour of daily stimulation, 7 days a week, for a total of 4 weeks (28 hours). Both participants and outcomes assessors will remain blinded to group allocation.
Resting-state EEG and cognitive assessments will be conducted at three time points: prior to the intervention (T1), post one-hour intervention (T2), and post one-month intervention (T3). Resting-state brainwave activity will be the primary outcome, with data collected at all three time points (T1, T2, and T3). As secondary outcomes, cognitive assessments will be administered at T1 and T3. Adverse events will also be recorded by participants immediately following each light stimulation session.
The primary aim of this study is to assess the immediate (T2 relative to T1) and long-term (T3 relative to T1) effects of endogenous gamma light stimulation on resting-state brainwave activity. Secondary objectives include evaluating cognitive performance and assessing the safety, user acceptance, and adherence to the intervention device. The results of this study will provide valuable insights into the potential of endogenous gamma light stimulation as a non-pharmacological intervention for cognitive decline in aging populations.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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endogenous gamma light
This device is an LED light source table lamp with a vertical surface measuring 16 cm by 22 cm. It will be positioned within arm's reach, approximately 50 cm from the participant, to ensure continuous exposure to the light stimulation. The active device delivers endogenous gamma light stimulation.
Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)
Participants will receive light stimulation using the Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) for 1 hour per day, 7 days a week, over 4 weeks, for a total of 28 hours.
Sham (70Hz) gamma light
The sham device is identical in appearance to the active device. It will be positioned within arm's reach, approximately 50 cm from the participant, to ensure continuous exposure to the light stimulation. The sham device delivers 70 Hz light stimulation.
Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)
Participants will receive light stimulation using the Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) for 1 hour per day, 7 days a week, over 4 weeks, for a total of 28 hours.
Interventions
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Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)
Participants will receive light stimulation using the Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) for 1 hour per day, 7 days a week, over 4 weeks, for a total of 28 hours.
Eligibility Criteria
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Inclusion Criteria
* 2\. The Cognitive Abilities Screening Instrument (CASI) score is within normal ranges adjusted for age and education.
* 3\. Participants have no history of severe neurological or psychiatric disorders (such as stroke, epilepsy, depression, migraine, etc.) that could affect cognitive function.
* 4\. Participants have not used drugs that may affect cognitive function (e.g., benzodiazepines, anticholinergic medications, etc.).
* 5\. Participants with normal or corrected vision (e.g., glasses or contact lenses) to normal levels.
* 6\. Voluntary to sign the Informed Consent Form.
Exclusion Criteria
* 2\. Participants with a history of disease that could affect cognitive function (e.g., cancer, autoimmune diseases, etc.).
* 3\. Pregnant, or planning to become pregnant.
55 Years
ALL
Yes
Sponsors
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Aleddra, Inc.
INDUSTRY
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Chang Gung University
Taoyuan District, Guishan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chia-Hsiung Cheng, Ph.D.
Role: primary
Chia-Hsiung Cheng, Ph.D.
Role: backup
Other Identifiers
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202401421B0A3
Identifier Type: -
Identifier Source: org_study_id