NCT06234930

The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation

The Feasibility, Safety and Tolerability of Virtual Reality-based Audiovisual Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Clarity Health Technologies, Inc · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Aging
• Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	Audiovisual stimulation VR system	Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.

Timeline

• Start date: 2024-07-11
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2024-01-31
• Last updated: 2025-09-02

Locations

2 sites across 1 country: United States