CClinicalTrials.gg
CompletedNCT06234930CFSUpdated Sep 2, 2025

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Aging
  • Alzheimer's Disease

Browse trials for

Keywords

  • Sensory neurostimulation
  • Non-invasive neuromodulation
  • Alzheimer's Disease
  • AD
  • Healthy
  • 50-90 years old
  • Gamma sensory stimulation
  • Virtual Reality
  • MCI
03

In context

Alzheimer Disease

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria Mild AD/ MCI due to AD Participants:

  • Age between 50 - 90 years old.
  • A clinical diagnosis of Mild Cognitive Impairment due to Alzheimer's disease (confirmed by PET scan or CSF biomarkers) or Mild Alzheimer's disease
  • MoCA score of 18-25.
  • Willingness to sign informed consent document (if deemed to not have the capacity to sign the informed consent, a legally authorized representative will be asked to provide surrogate consent).
  • Sufficient visual and hearing ability.
  • Formal education of 8 or more years.
  • Native English speakers or demonstrated fluency in English (participant; and LAR as needed)

Inclusion Criteria Cognitively Healthy Participants:

  • Age between 50 - 90 years old.
  • A MoCA score above or equal to 26.
  • Willingness to sign informed consent document.
  • Sufficient visual and hearing ability.
  • Formal education of 8 or more years.
  • Native English speakers or demonstrated fluency in English (participant)

Exclusion Criteria Mild AD/ MCI due to AD Participants:

  • Previous exposure to monoclonal antibody medication (e.g., Lecanemab, Aducanumab).
  • Active treatment with Memantine within the past 30 days.
  • Initiation of acetylcholinesterase inhibitors within the past 30 days.
  • A history of seizure or epilepsy including family history of seizure or epilepsy.
  • A history of stroke.
  • A diagnosis of migraine headache.
  • History of alcohol use disorder within the past 2 years (DSM-V criteria).
  • Current or past history of any neurological disorder other than dementia.
  • Use of hearing aid device(s).
  • Any known blood pathogens or disorders.
  • Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities.
  • Pregnancy (Verbal confirmation).
  • Geriatric Depression Scale (GDS) >8

Exclusion Criteria Cognitively Healthy Participants:

  • Active treatment with Memantine within the past 30 days.
  • Initiation of treatment with acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine and galantamine) within the past 30 days.
  • A history of seizure or epilepsy including family history of seizure or epilepsy.
  • A history of stroke.
  • A diagnosis of migraine headache.
  • History of alcohol use disorder within the past 2 years (DSM-V criteria).
  • Use of hearing aid device(s).
  • Any known blood pathogens or disorders.
  • A diagnosis of Alzheimer's disease and related dementias.
  • Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities.
  • Pregnancy (Verbal confirmation)
  • Geriatric Depression Scale (GDS) >8
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD):

    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

  • Experimental
    Active and Sham Audiovisual Stimulation (Cognitively Healthy):

    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

Interventions

  • DeviceAudiovisual 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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

2 sites
  • The Sequoias Portola Valley
    Portola Valley, California 18503, United States
  • Lakeview Institute of Clinical Research LLC
    Leesburg, Florida 34748, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06234930
Lead sponsor
Clarity Health Technologies, Inc
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Jul 11, 2024
Primary completion
Mar 14, 2025
Completion
Mar 14, 2025
Last update
Sep 2, 2025

Study contacts

Carolina Reis, PhD
principal investigator · Clarity Health Technologies

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion