An interventional study of Audiovisual stimulation VR system in Healthy Aging and Alzheimer's Disease, sponsored by Clarity Health Technologies, Inc. Completed at 2 sites in United States. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Clarity Health Technologies, Inc · Not applicable, Interventional, and Treatment
This is a single-blind, sham-controlled, clinical trial that aims to evaluate the safety, tolerability, and feasibility of delivering audiovisual stimulation via a Virtual Reality (VR) headset to people cognitively impaired due to Alzheimer's and cognitively unimpaired people.
Audiovisual stimulation is a non-invasive approach that uses synchronized light and sound stimuli to modulate neural activity and cognitive processes.
Recent literature suggests that when applied chronically, audiovisual stimulation may slow down the progression of Alzheimer's disease (AD). In contrast to traditional methods employing Light Emitting Diodes (LEDs) and computer screens for the delivery of visual stimuli, our study explores the feasibility, safety, and tolerability of delivering acute audiovisual stimulation via a Virtual Reality (VR) headset.
The investigators plan to recruit a total of 50 participants (n=25 mild AD or MCI due to AD and n=25 cognitively healthy participants). Audiovisual stimulation will be delivered over one experimental session to every participant. Stimuli will be embedded in passive environments and in a sound-video associative memory task. All participants will be exposed to stimulation at different frequencies and a sham condition will be used as a control. To determine the feasibility of VR-based audiovisual stimulation, the investigators will use electroencephalography (EEG) and measure the responsiveness of participants' brain activity to the acute intervention. Safety and tolerability will be evaluated using questionnaires.
This clinical trial aims to provide valuable insights into the development of a non-invasive therapy for early-stage Alzheimer's disease, while assessing the feasibility and safety of using VR technology to deliver audiovisual stimulation.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 27 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Clarity Health Technologies, Inc is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Mild AD/ MCI due to AD Participants:
Inclusion Criteria Cognitively Healthy Participants:
Exclusion Criteria Mild AD/ MCI due to AD Participants:
Exclusion Criteria Cognitively Healthy Participants:
Both active and sham stimulation conditions will be delivered to 25 cognitively impaired participants to demonstrate the mechanism of action of the intervention.
Device: Audiovisual stimulation VR system
Both active and sham stimulation conditions will be delivered to 25 healthy participants to demonstrate the mechanism of action of the intervention.
Device: Audiovisual stimulation VR system
Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.
Also known as: VR-based audiovisual stimulation, Sensory stimulation
Changes in brain activity associated with exposure to VR-based audiovisual stimulation
Feasibility of VR-based audiovisual stimulation will be assessed by quantifying significant changes in participants' brainwave activity during varying stimulation frequencies in comparison to baseline.
Time frame: Immediately after the intervention
Level of tolerance to VR-based sensory stimulation exposure
Tolerability will be assessed using a Likert scale ranging from 1 (indicating poor) to 7 (indicating good) to evaluate the overall VR-based sensory stimulation experience.
Time frame: Immediately after the intervention
Incidence of Stimulation-Emergent Adverse Events
Safety will be assessed via a questionnaire asking for any stimulation-related adverse effects.
Time frame: Immediately after the intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Clarity Health Technologies, Inc